The following data is part of a premarket notification filed by Pall Medical with the FDA for Pall Ultipor Anesthesia Breathing System.
| Device ID | K013093 |
| 510k Number | K013093 |
| Device Name: | PALL ULTIPOR ANESTHESIA BREATHING SYSTEM |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | PALL MEDICAL 600 S. WAGNER RD. Ann Arbor, MI 48103 |
| Contact | Leonard S Berman |
| Correspondent | Leonard S Berman PALL MEDICAL 600 S. WAGNER RD. Ann Arbor, MI 48103 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-17 |
| Decision Date | 2002-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30636207315459 | K013093 | 000 |
| 30636207315282 | K013093 | 000 |
| 30636207315275 | K013093 | 000 |
| 30636207315268 | K013093 | 000 |
| 30636207315251 | K013093 | 000 |
| 30636207315244 | K013093 | 000 |
| 30636207315237 | K013093 | 000 |
| 30636207315213 | K013093 | 000 |
| 30636207315206 | K013093 | 000 |
| 30636207315190 | K013093 | 000 |
| 30636207315183 | K013093 | 000 |
| 30636207305467 | K013093 | 000 |
| 30636207315299 | K013093 | 000 |
| 30636207315305 | K013093 | 000 |
| 30636207315312 | K013093 | 000 |
| 30636207315428 | K013093 | 000 |
| 30636207315411 | K013093 | 000 |
| 30636207315404 | K013093 | 000 |
| 30636207315398 | K013093 | 000 |
| 30636207315381 | K013093 | 000 |
| 30636207315374 | K013093 | 000 |
| 30636207315367 | K013093 | 000 |
| 30636207315350 | K013093 | 000 |
| 30636207315343 | K013093 | 000 |
| 30636207315336 | K013093 | 000 |
| 30636207315329 | K013093 | 000 |
| 30636207302985 | K013093 | 000 |