The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Disposable, Hyperbaric Oxygen Chamber.
Device ID | K840817 |
510k Number | K840817 |
Device Name: | DISPOSABLE, HYPERBARIC OXYGEN CHAMBER |
Classification | Chamber, Oxygen, Topical, Extremity |
Applicant | HOSPITAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPJ |
CFR Regulation Number | 878.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-24 |
Decision Date | 1984-04-25 |