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 |