The following data is part of a premarket notification filed by Falck Medical, Inc with the FDA for Falck Medical Multifunction Tonometer, Fat1.
| Device ID | K151491 |
| 510k Number | K151491 |
| Device Name: | Falck Medical Multifunction Tonometer, FAT1 |
| Classification | Tonometer, Manual |
| Applicant | FALCK MEDICAL, INC 35 WASHINGTON STREET Mystic, CT 06355 |
| Contact | Francis Falck |
| Correspondent | Francis Falck FALCK MEDICAL, INC 35 WASHINGTON STREET Mystic, CT 06355 |
| 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 | 2015-06-03 |
| Decision Date | 2016-01-15 |
| Summary: | summary |