RONDEX CPR ISO-SHIELD— 510(k) K981169

Substantially Equivalent

Rondex Products, Inc.

FDA 510(k) clearance K981169 for RONDEX CPR ISO-SHIELD, Substantially Equivalent on 1998-05-19. Applicant: Rondex Products, Inc.. Device class: 2.

Clearance details

Applicant: Rondex Products, Inc.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 1998-03-30
Decision date: 1998-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockford, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Rondex Products, Inc.

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
K914196 — RONDEX MASKS MODELS 9015/9011/901102 MODIFIED1991-11-08

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