The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Lspi Infant Bag Mask.
| Device ID | K921553 |
| 510k Number | K921553 |
| Device Name: | LSPI INFANT BAG MASK |
| 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 | 1992-04-01 |
| Decision Date | 1992-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720000722 | K921553 | 000 |
| 00026072000694 | K921553 | 000 |
| 00026072000700 | K921553 | 000 |
| 00026072000717 | K921553 | 000 |
| 00026072000724 | K921553 | 000 |
| 00260720000685 | K921553 | 000 |
| 00260720000692 | K921553 | 000 |
| 00260720000708 | K921553 | 000 |
| 00260720000715 | K921553 | 000 |
| 00026072000687 | K921553 | 000 |