JEMSDAL MASK— 510(k) K942907

Substantially Equivalent

Respan Products, Inc.

FDA 510(k) clearance K942907 for JEMSDAL MASK, Substantially Equivalent on 1994-08-31. Applicant: Respan Products, Inc.. Device class: 1.

Clearance details

Applicant: Respan Products, Inc.
Product code: Code BYG
Device class: Class 1
Regulation: 21 CFR 868.5580
Advisory panel: Anesthesiology
Date received: 1994-06-21
Decision date: 1994-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewiston, NY, US

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Recent devices under product code BYG

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K945482 — DISPOSABLE, CPAP OXYGEN MASK1995-09-19
K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK1995-09-18
K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS1995-09-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.