The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Vital Statistics System (o-cath Accessory).
| Device ID | K964978 |
| 510k Number | K964978 |
| Device Name: | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) |
| Classification | Oximeter |
| Applicant | QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Contact | Matthew Hedlund |
| Correspondent | Matthew Hedlund QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-12 |
| Decision Date | 1997-05-21 |
| Summary: | summary |