CPR VALVE (NON-REBREATHING) MODEL #9030

Valve, Non-rebreathing

RONDEX PRODUCTS, INC.

The following data is part of a premarket notification filed by Rondex Products, Inc. with the FDA for Cpr Valve (non-rebreathing) Model #9030.

Pre-market Notification Details

• Device ID: K902299
• 510k Number: K902299
• Device Name: CPR VALVE (NON-REBREATHING) MODEL #9030
• Classification: Valve, Non-rebreathing
• Applicant: RONDEX PRODUCTS, INC. P.O. BOX NO. 1829 Rockford, IL 61110
• Contact: Gene R Baldwin
• Correspondent: Gene R Baldwin; RONDEX PRODUCTS, INC. P.O. BOX NO. 1829 Rockford, IL 61110
• Product Code: CBP
• CFR Regulation Number: 868.5870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-05-22
• Decision Date: 1990-10-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06343760091234	K902299	000
06343760091203	K902299	000
06343760020203	K902299	000