The following data is part of a premarket notification filed by Beta Biomed Services, Inc. with the FDA for Preamp Cable, Model B400-1011pa.
| Device ID | K003542 |
| 510k Number | K003542 |
| Device Name: | PREAMP CABLE, MODEL B400-1011PA |
| Classification | Oximeter |
| Applicant | BETA BIOMED SERVICES, INC. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | Ej Smith |
| Correspondent | Ej Smith BETA BIOMED SERVICES, INC. P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-17 |
| Decision Date | 2001-04-06 |