The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Keeler Pulsair Non Contact Tonometer, Modification.
| Device ID | K911721 |
| 510k Number | K911721 |
| Device Name: | KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION |
| Classification | Tonometer, Ac-powered |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Van Arsdale |
| Correspondent | Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-17 |
| Decision Date | 1991-06-25 |