Cleared Traditional

K842607 - INFANT APNEA BED STIMULATOR AA-010 (FDA 510(k) Clearance)

K842607 · Alpha Medical Systems · General Hospital
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Sep 1984
Decision
70d
Days
-
Risk

K842607 is an FDA 510(k) clearance for the INFANT APNEA BED STIMULATOR AA-010.

Submitted by Alpha Medical Systems (Mchenry, US). The FDA issued a Cleared decision on September 13, 1984 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K842607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1984
Decision Date September 13, 1984
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 128d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -