The following data is part of a premarket notification filed by Falck Medical Inc. with the FDA for Falck Applanation Tonometer (fat2).
| Device ID | K071755 |
| 510k Number | K071755 |
| Device Name: | FALCK APPLANATION TONOMETER (FAT2) |
| Classification | Tonometer, Manual |
| Applicant | FALCK MEDICAL INC. 15825 SHADY GROVE RD.,SUITE 30 Rockville, MD 20850 |
| Contact | Richard E Lippman |
| Correspondent | Richard E Lippman FALCK MEDICAL INC. 15825 SHADY GROVE RD.,SUITE 30 Rockville, MD 20850 |
| Product Code | HKY |
| Subsequent Product Code | HPK |
| Subsequent Product Code | NJJ |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-28 |
| Decision Date | 2008-06-03 |
| Summary: | summary |