The following data is part of a premarket notification filed by Agilent Technologies with the FDA for Digital Holter Recorder.
| Device ID | K942781 |
| 510k Number | K942781 |
| Device Name: | DIGITAL HOLTER RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | AGILENT TECHNOLOGIES 20 N.AVIADOR ST. Camarillo, CA 95010 |
| Contact | J. Dudley Harris |
| Correspondent | J. Dudley Harris AGILENT TECHNOLOGIES 20 N.AVIADOR ST. Camarillo, CA 95010 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-13 |
| Decision Date | 1995-01-24 |