The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Henson - Hamblin Cfs 2000 Central Field Screen.
| Device ID | K864467 |
| 510k Number | K864467 |
| Device Name: | HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN |
| Classification | Perimeter, 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 | HOO |
| CFR Regulation Number | 886.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-12 |
| Decision Date | 1986-12-15 |