The following data is part of a premarket notification filed by Burdick, Inc. with the FDA for Altair 6100 Cassette Recorder.
| Device ID | K942438 |
| 510k Number | K942438 |
| Device Name: | ALTAIR 6100 CASSETTE RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | BURDICK, INC. 15 PLUMB ST. Milton, WI 53563 -1499 |
| Contact | Paul Appel |
| Correspondent | Paul Appel BURDICK, INC. 15 PLUMB ST. Milton, WI 53563 -1499 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-20 |
| Decision Date | 1994-08-05 |