The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Pulsair Intellipuff, Pulsair Desktop Model 2414-p-2001, 2417-p-2000.
| Device ID | K093298 |
| 510k Number | K093298 |
| Device Name: | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 |
| Classification | Tonometer, Ac-powered |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Eugene Van Arsdale |
| Correspondent | Eugene 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 | 2009-10-21 |
| Decision Date | 2010-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272711746 | K093298 | 000 |
| 05055272707237 | K093298 | 000 |