The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Easy Pulse Ii Oxygen Conserver.
| Device ID | K032018 |
| 510k Number | K032018 |
| Device Name: | EASY PULSE II OXYGEN CONSERVER |
| Classification | Conserver, Oxygen |
| Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Contact | James Parker |
| Correspondent | James Parker PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-30 |
| Decision Date | 2003-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855887006719 | K032018 | 000 |
| 00855887006948 | K032018 | 000 |
| 00855887006627 | K032018 | 000 |
| 00855887006962 | K032018 | 000 |
| 00855887006979 | K032018 | 000 |