The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Lsp (model 554) Bag Mask Resuscitator.
| Device ID | K922691 |
| 510k Number | K922691 |
| Device Name: | LSP (MODEL 554) BAG MASK RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718 |
| Contact | Vernon Trimble |
| Correspondent | Vernon Trimble LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-04 |
| Decision Date | 1993-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720001019 | K922691 | 000 |
| 00026072001004 | K922691 | 000 |
| 00026072000991 | K922691 | 000 |
| 00026072000984 | K922691 | 000 |
| 00026072000977 | K922691 | 000 |
| 00026072000960 | K922691 | 000 |
| 00026072000953 | K922691 | 000 |
| 00026072000946 | K922691 | 000 |
| 00026072000939 | K922691 | 000 |
| 00026072000922 | K922691 | 000 |
| 00026072001011 | K922691 | 000 |
| 00260720000913 | K922691 | 000 |
| 00260720001002 | K922691 | 000 |
| 00260720000999 | K922691 | 000 |
| 00260720000982 | K922691 | 000 |
| 00260720000975 | K922691 | 000 |
| 00260720000968 | K922691 | 000 |
| 00260720000951 | K922691 | 000 |
| 00260720000944 | K922691 | 000 |
| 00260720000937 | K922691 | 000 |
| 00260720000920 | K922691 | 000 |
| 00026072000915 | K922691 | 000 |