The following data is part of a premarket notification filed by Associated Medical Representatives with the FDA for Amr Research Tonometer.
| Device ID | K862958 |
| 510k Number | K862958 |
| Device Name: | AMR RESEARCH TONOMETER |
| Classification | Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical |
| Applicant | ASSOCIATED MEDICAL REPRESENTATIVES 890 W. 70TH PL. P.O. BOX 21345 Denver, CO 80221 |
| Contact | Carol E Finkbeiner |
| Correspondent | Carol E Finkbeiner ASSOCIATED MEDICAL REPRESENTATIVES 890 W. 70TH PL. P.O. BOX 21345 Denver, CO 80221 |
| Product Code | LCH |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-05 |
| Decision Date | 1986-11-24 |