The following data is part of a premarket notification filed by Precision Medical Inc. with the FDA for Accu O2 Oxygen Analyzer.
| Device ID | K173807 |
| 510k Number | K173807 |
| Device Name: | Accu O2 Oxygen Analyzer |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | Precision Medical Inc. 300 Held Drive Northampton, PA 18067 |
| Contact | James Parker |
| Correspondent | James Parker Precision Medical Inc. 300 Held Drive 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 | 2017-12-15 |
| Decision Date | 2018-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855887006870 | K173807 | 000 |