The following data is part of a premarket notification filed by Rondex Products, Inc. with the FDA for Rondex Cpr Iso-shield.
| Device ID | K981169 |
| 510k Number | K981169 |
| Device Name: | RONDEX CPR ISO-SHIELD |
| Classification | Device, Cpr Assist |
| 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 | LYM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-30 |
| Decision Date | 1998-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06343760098578 | K981169 | 000 |
| 06343760098073 | K981169 | 000 |
| 06343760098004 | K981169 | 000 |
| 00634376098004 | K981169 | 000 |
| 00634376098073 | K981169 | 000 |