The following data is part of a premarket notification filed by Advanced Warming Systems, Inc. with the FDA for Safecircuit Manifold/pulmonary Unit.
| Device ID | K953269 |
| 510k Number | K953269 |
| Device Name: | SAFECIRCUIT MANIFOLD/PULMONARY UNIT |
| Classification | Apparatus, Gas-scavenging |
| Applicant | ADVANCED WARMING SYSTEMS, INC. 3414 22ND ST. Lubbock, TX 79410 |
| Contact | Randy Hickle |
| Correspondent | Randy Hickle ADVANCED WARMING SYSTEMS, INC. 3414 22ND ST. Lubbock, TX 79410 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-13 |
| Decision Date | 1996-12-20 |
| Summary: | summary |