The following data is part of a premarket notification filed by On Site Gas Systems, Inc. with the FDA for Pogs, Model 65/130.
Device ID | K092636 |
510k Number | K092636 |
Device Name: | POGS, MODEL 65/130 |
Classification | Generator, Oxygen, Portable |
Applicant | ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. Newington, CT 06111 |
Contact | Guy Hatch |
Correspondent | Guy Hatch ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. Newington, CT 06111 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-27 |
Decision Date | 2010-01-07 |
Summary: | summary |