THUNDERBEAT
Electrosurgical, Cutting & Coagulation & Accessories
OLYMPUS MEDICAL SYSTEMS CORP.
The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Thunderbeat.
Pre-market Notification Details
| Device ID | K132703 |
| 510k Number | K132703 |
| Device Name: | THUNDERBEAT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 136 TURNPIKE ROAD REGULATORY AFFAIRS DIVISION Southborough, MA 01772 |
| Contact | Graham Baillie |
| Correspondent | Graham Baillie OLYMPUS MEDICAL SYSTEMS CORP. 136 TURNPIKE ROAD REGULATORY AFFAIRS DIVISION Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-29 |
| Decision Date | 2014-05-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170343312 | K132703 | 000 |
| 14953170343305 | K132703 | 000 |
Trademark Results [THUNDERBEAT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THUNDERBEAT 77551145 4158074 Live/Registered |
OLYMPUS CORPORATION 2008-08-20 |
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