The following data is part of a premarket notification filed by Medical Technology Specialists, Inc. with the FDA for Pro2 Check Oxygen Indicator.
| Device ID | K983500 |
| 510k Number | K983500 |
| Device Name: | PRO2 CHECK OXYGEN INDICATOR |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | MEDICAL TECHNOLOGY SPECIALISTS, INC. 6290-D WARWICK RD. Richmond, VA 23224 |
| Contact | Donald W Morrow, Iii |
| Correspondent | Donald W Morrow, Iii MEDICAL TECHNOLOGY SPECIALISTS, INC. 6290-D WARWICK RD. Richmond, VA 23224 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-06 |
| Decision Date | 1999-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607411918971 | K983500 | 000 |
| 00607411918964 | K983500 | 000 |
| 00607411915987 | K983500 | 000 |
| 00607411890093 | K983500 | 000 |