The following data is part of a premarket notification filed by Sony Medical Systems with the FDA for Sony Pgm-100p1md Trinitron Color Graphic Monitor.
| Device ID | K970999 |
| 510k Number | K970999 |
| Device Name: | SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-19 |
| Decision Date | 1997-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04905524818321 | K970999 | 000 |
| 04905524774191 | K970999 | 000 |
| 04905524650792 | K970999 | 000 |
| 04905524572445 | K970999 | 000 |