Cleared Traditional

K970763 - MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR

K970763 is an FDA 510(k) clearance for MODULAR TELEMETRY SYSTEM (MTS) OPTION F..., manufactured by Medical Data Electronics. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K970763 · Medical Data Electronics · Anesthesiology device
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Jul 1997
Decision
133d
Days
Class 2
Risk

K970763 is an FDA 510(k) clearance for the MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on July 14, 1997 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Data Electronics devices

FDA 510(k) Submission Details - K970763

510(k) Number K970763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1997
Decision Date July 14, 1997
Days to Decision 133 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 140d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 664
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K970763.
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
K971828 · Alexander Mfg. Co. · Aug 1997
COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67
K964821 · Ventrex, Inc. · Jul 1997
OXIMETER PRE-AMP CABLE
K965172 · Epic Medical Equipment Services, Inc. · Jul 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W
K971235 · Alexander Mfg. Co. · Jun 1997
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
K964978 · Quinton, Inc. · May 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · Siemens Medical Solutions USA, Inc. · May 1997