The following data is part of a premarket notification filed by Beta Biomed Services, Inc. with the FDA for Vitalsat Series.
| Device ID | K011518 |
| 510k Number | K011518 |
| Device Name: | VITALSAT SERIES |
| Classification | Oximeter |
| Applicant | BETA BIOMED SERVICES, INC. 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | E J Smith |
| Correspondent | E J Smith BETA BIOMED SERVICES, INC. 1468 HARWELL AVE. 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 | 2001-05-17 |
| Decision Date | 2002-11-15 |