The following data is part of a premarket notification filed by Sony Medical Systems with the FDA for Sony Dkr-700 Digital Still Recorder.
| Device ID | K961680 |
| 510k Number | K961680 |
| Device Name: | SONY DKR-700 DIGITAL STILL RECORDER |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | SONY MEDICAL SYSTEMS C/O MEDICAL DEVICE CONSULT,INC 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair SONY MEDICAL SYSTEMS C/O MEDICAL DEVICE CONSULT,INC 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-01 |
| Decision Date | 1996-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548736103146 | K961680 | 000 |
| 04548736103160 | K961680 | 000 |