The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Precision Portable Oxygen Concentration Model 4150.
| Device ID | K103563 |
| 510k Number | K103563 |
| Device Name: | PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 |
| Classification | Generator, Oxygen, Portable |
| 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 | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2011-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855887006887 | K103563 | 000 |
| 00855887006696 | K103563 | 000 |