The following data is part of a premarket notification filed by Cryogenic Assoc. with the FDA for Portable Gaseous Oxgyen Container.
| Device ID | K852663 |
| 510k Number | K852663 |
| Device Name: | PORTABLE GASEOUS OXGYEN CONTAINER |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | CRYOGENIC ASSOC. 6565 COFFMAN RD. Indianapolis, IN 46268 |
| Contact | Steve Lindamood |
| Correspondent | Steve Lindamood CRYOGENIC ASSOC. 6565 COFFMAN RD. Indianapolis, IN 46268 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-24 |
| Decision Date | 1985-08-29 |