The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Mass Spectrometer-medspect Ii.
| Device ID | K810938 |
| 510k Number | K810938 |
| Device Name: | MASS SPECTROMETER-MEDSPECT II |
| Classification | Mass Spectrometer, Clinical Use |
| Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DOP |
| CFR Regulation Number | 862.2860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-07 |
| Decision Date | 1981-04-23 |