The following data is part of a premarket notification filed by Progressive Medical Applications Corp. with the FDA for Rx02 Emergency Medical Oxygen.
| Device ID | K895956 |
| 510k Number | K895956 |
| Device Name: | RX02 EMERGENCY MEDICAL OXYGEN |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | PROGRESSIVE MEDICAL APPLICATIONS CORP. 1251 S. CEDAR CREST BLVD. SUITE 207D Allentown, PA 18103 |
| Contact | John A Schlosberg |
| Correspondent | John A Schlosberg PROGRESSIVE MEDICAL APPLICATIONS CORP. 1251 S. CEDAR CREST BLVD. SUITE 207D Allentown, PA 18103 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-11 |
| Decision Date | 1990-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720011018 | K895956 | 000 |
| 00026072011010 | K895956 | 000 |