The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Wireless Image Transmitter Unit.
| Device ID | K120278 |
| 510k Number | K120278 |
| Device Name: | WIRELESS IMAGE TRANSMITTER UNIT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Sheri Musgnung |
| Correspondent | Sheri Musgnung OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-30 |
| Decision Date | 2012-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170327735 | K120278 | 000 |
| 04953170327711 | K120278 | 000 |
| 04953170327681 | K120278 | 000 |
| 04953170305016 | K120278 | 000 |