The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Oxygen Concentrator.
Device ID | K844328 |
510k Number | K844328 |
Device Name: | OXYGEN CONCENTRATOR |
Classification | Generator, Oxygen, Portable |
Applicant | HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
Contact | William J Lacey |
Correspondent | William J Lacey HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-07 |
Decision Date | 1984-12-04 |