The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Model 6200 Oxygen Concentrator.
Device ID | K813320 |
510k Number | K813320 |
Device Name: | MODEL 6200 OXYGEN CONCENTRATOR |
Classification | Generator, Oxygen, Portable |
Applicant | HUDSON OXYGEN THERAPY SALES CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-24 |
Decision Date | 1981-12-31 |