The following data is part of a premarket notification filed by Medical Associated Services, Inc. with the FDA for Panda Helium Gas Analyzer.
| Device ID | K903939 |
| 510k Number | K903939 |
| Device Name: | PANDA HELIUM GAS ANALYZER |
| Classification | Analyzer, Gas, Helium, Gaseous-phase |
| Applicant | MEDICAL ASSOCIATED SERVICES, INC. P.O. BOX 530 Hatfield, PA 19440 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge MEDICAL ASSOCIATED SERVICES, INC. P.O. BOX 530 Hatfield, PA 19440 |
| Product Code | BSE |
| CFR Regulation Number | 868.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-27 |
| Decision Date | 1991-01-03 |