The following data is part of a premarket notification filed by Sun Medical Equipment, Inc. with the FDA for Sun Model Oa 3000 Oxygen Analyzer.
| Device ID | K952941 |
| 510k Number | K952941 |
| Device Name: | SUN MODEL OA 3000 OXYGEN ANALYZER |
| Classification | Generator, Oxygen, Portable |
| Applicant | SUN MEDICAL EQUIPMENT, INC. 1825 S. DIVISION AVE. Orlando, FL 32806 |
| Contact | Danny Sheetz |
| Correspondent | Danny Sheetz SUN MEDICAL EQUIPMENT, INC. 1825 S. DIVISION AVE. Orlando, FL 32806 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-26 |
| Decision Date | 1996-01-29 |