RONDEX RESCUE MASK— 510(k) K881393

Substantially Equivalent

Rondex Products, Inc.

FDA 510(k) clearance K881393 for RONDEX RESCUE MASK, Substantially Equivalent on 1988-04-25. Applicant: Rondex Products, Inc.. Device class: 1.

Clearance details

Applicant: Rondex Products, Inc.
Product code: Code BSJ
Device class: Class 1
Regulation: 21 CFR 868.5550
Advisory panel: Anesthesiology
Date received: 1988-04-04
Decision date: 1988-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockford, IL, US

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More clearances from Rondex Products, Inc.

K981169 — RONDEX CPR ISO-SHIELD1998-05-19
K942671 — CPR SHIELD1995-02-07
K943761 — NON-BREATHING VALVE1994-11-10
K921002 — RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED1992-10-06
K914195 — RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED1991-11-08

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