The following data is part of a premarket notification filed by Superior Products, Inc. with the FDA for Oxy-serve Ii Oxygen Conserving Regulator.
| Device ID | K051988 |
| 510k Number | K051988 |
| Device Name: | OXY-SERVE II OXYGEN CONSERVING REGULATOR |
| Classification | Conserver, Oxygen |
| Applicant | SUPERIOR PRODUCTS, INC. 3786 RIDGE RD. Cleveland, OH 44144 |
| Contact | Ronald Johnston |
| Correspondent | Ronald Johnston SUPERIOR PRODUCTS, INC. 3786 RIDGE RD. Cleveland, OH 44144 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-22 |
| Decision Date | 2005-09-21 |
| Summary: | summary |