Company ยท US
Rondex Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1998. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 1998 | K981169 | RONDEX CPR ISO-SHIELD Rondex Products, Inc. | CBP |
| Feb 7, 1995 | K942671 | CPR SHIELD Rondex Products, Inc. | CBP |
| Nov 10, 1994 | K943761 | NON-BREATHING VALVE Rondex Products, Inc. | CBP |
| Oct 6, 1992 | K921002 | RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED Rondex Products, Inc. | BTM |
| Nov 8, 1991 | K914196 | RONDEX MASKS MODELS 9015/9011/901102 MODIFIED Rondex Products, Inc. | BTM |
| Nov 8, 1991 | K914195 | RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED Rondex Products, Inc. | CBP |
| Oct 26, 1990 | K902299 | CPR VALVE (NON-REBREATHING) MODEL #9030 Rondex Products, Inc. | CBP |
| Aug 22, 1990 | K902298 | ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS Rondex Products, Inc. | BSJ |
| Jul 21, 1988 | K881931 | RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR Rondex Products, Inc. | CBP |
| Apr 25, 1988 | K881393 | RONDEX RESCUE MASK Rondex Products, Inc. | BSJ |
| Jan 18, 1984 | K834250 | RESCUE MASK Rondex Products, Inc. | BTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||