The following data is part of a premarket notification filed by Rondex Products, Inc. with the FDA for Rondex Masks Models 9015/9011/901102 Modified.
| Device ID | K914196 |
| 510k Number | K914196 |
| Device Name: | RONDEX MASKS MODELS 9015/9011/901102 MODIFIED |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-05 |
| Decision Date | 1991-11-08 |