The following data is part of a premarket notification filed by Burdick, Inc. with the FDA for Pc Holter Scanning System Simplicity, Altair 8200, 8300, 8400.
| Device ID | K945985 |
| 510k Number | K945985 |
| Device Name: | PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | BURDICK, INC. 15 PLUMB ST. Milton, WI 53563 -1499 |
| Contact | Richard J Berk |
| Correspondent | Richard J Berk BURDICK, INC. 15 PLUMB ST. Milton, WI 53563 -1499 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-08 |
| Decision Date | 1995-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10812345029939 | K945985 | 000 |