The following data is part of a premarket notification filed by Burdick, Inc. with the FDA for Burdick 200 Pulse Oximeter.
| Device ID | K954267 |
| 510k Number | K954267 |
| Device Name: | BURDICK 200 PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | BURDICK, INC. 15 PLUMB ST. Milton, WI 53563 -1499 |
| Contact | Paul E Appel |
| Correspondent | Paul E Appel BURDICK, INC. 15 PLUMB ST. Milton, WI 53563 -1499 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-12 |
| Decision Date | 1996-05-03 |
| Summary: | summary |