The following data is part of a premarket notification filed by Pan-america Hyperbarics, Inc. with the FDA for Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1.
Device ID | K122560 |
510k Number | K122560 |
Device Name: | VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 |
Classification | Ventilator, Continuous, Facility Use |
Applicant | PAN-AMERICA HYPERBARICS, INC. 1510 PARK PLACE DRIVE Atchison, KS 66002 |
Contact | William M Gates, Rrt |
Correspondent | William M Gates, Rrt PAN-AMERICA HYPERBARICS, INC. 1510 PARK PLACE DRIVE Atchison, KS 66002 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-22 |
Decision Date | 2013-03-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04719872000006 | K122560 | 000 |