The following data is part of a premarket notification filed by Metron U.s., Inc. with the FDA for Metron Qa-510 Spo2 Analyzer.
| Device ID | K973991 |
| 510k Number | K973991 |
| Device Name: | METRON QA-510 SPO2 ANALYZER |
| Classification | Oximeter |
| Applicant | METRON U.S., INC. P.O. BOX 4343 Crofton, MD 21114 -4341 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith METRON U.S., INC. P.O. BOX 4343 Crofton, MD 21114 -4341 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-21 |
| Decision Date | 1998-01-16 |