The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Precision Oxygen Monitor.
| Device ID | K063096 |
| 510k Number | K063096 |
| Device Name: | PRECISION OXYGEN MONITOR |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| 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 | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-10 |
| Decision Date | 2007-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855887006702 | K063096 | 000 |
| 00855887006993 | K063096 | 000 |