The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Keeler Pulsair Non Contact Tonometer.
Device ID | K870750 |
510k Number | K870750 |
Device Name: | KEELER PULSAIR NON CONTACT TONOMETER |
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 | 1987-02-25 |
Decision Date | 1987-03-17 |