The following data is part of a premarket notification filed by Mallinckrodt Anesthesia Products with the FDA for Cpap System And Broncho-cath W/cpap System.
| Device ID | K912240 |
| 510k Number | K912240 |
| Device Name: | CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | MALLINCKRODT ANESTHESIA PRODUCTS HOOK RD. Argyle, NY 12809 |
| Contact | Lynn C Stimpson |
| Correspondent | Lynn C Stimpson MALLINCKRODT ANESTHESIA PRODUCTS HOOK RD. Argyle, NY 12809 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-21 |
| Decision Date | 1991-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80884522011593 | K912240 | 000 |
| 10884521620032 | K912240 | 000 |
| 10884521620025 | K912240 | 000 |
| 10884521620018 | K912240 | 000 |
| 10884521620001 | K912240 | 000 |
| 10884521619999 | K912240 | 000 |
| 10884521831841 | K912240 | 000 |
| 10884521831834 | K912240 | 000 |
| 10884521831827 | K912240 | 000 |
| 10884521831810 | K912240 | 000 |
| 10884521831629 | K912240 | 000 |
| 10884521831612 | K912240 | 000 |
| 10884521831605 | K912240 | 000 |
| 10884521831599 | K912240 | 000 |
| 20884521831633 | K912240 | 000 |
| 10884521620049 | K912240 | 000 |
| 10884521620056 | K912240 | 000 |
| 60884522011599 | K912240 | 000 |
| 30884522029081 | K912240 | 000 |
| 30884522029074 | K912240 | 000 |
| 30884522008703 | K912240 | 000 |
| 30884522008697 | K912240 | 000 |
| 30884522008680 | K912240 | 000 |
| 30884522008673 | K912240 | 000 |
| 30884522008666 | K912240 | 000 |
| 30884522008659 | K912240 | 000 |
| 10884522029094 | K912240 | 000 |
| 10884522028981 | K912240 | 000 |
| 10884521620087 | K912240 | 000 |
| 10884521620070 | K912240 | 000 |
| 10884521620063 | K912240 | 000 |
| 20884521831640 | K912240 | 000 |