Cleared Traditional

K970763 - MODULAR TELEMETRY SYSTEM (MTS) OPTION F...

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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K970763.
NPB-190 PULSE OXIMETER (NPB-190)
K971946 · Nellcor Puritan Bennett, Inc. · Aug 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764
K971827 · Alexander Mfg. Co. · Aug 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
K971828 · Alexander Mfg. Co. · Aug 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