The following data is part of a premarket notification filed by Artel, Inc. with the FDA for Mp/s Single Wavelength Mini Photometer.
| Device ID | K920914 |
| 510k Number | K920914 |
| Device Name: | MP/S SINGLE WAVELENGTH MINI PHOTOMETER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | ARTEL, INC. 12 DEPOT ST. Windham, ME 04062 |
| Contact | Charles Ewing |
| Correspondent | Charles Ewing ARTEL, INC. 12 DEPOT ST. Windham, ME 04062 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-27 |
| Decision Date | 1992-03-23 |