The following data is part of a premarket notification filed by Zimmer Medizinsystems Gmbh with the FDA for Opton Pro.
| Device ID | K141564 |
| 510k Number | K141564 |
| Device Name: | OPTON PRO |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | ZIMMER MEDIZINSYSTEMS GMBH JUNKERSSTRASSE 9 Neu-ulm, DE 89231 |
| Contact | Armin Petraschka |
| Correspondent | Kirsten Langen TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-06-12 |
| Decision Date | 2014-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053815053972 | K141564 | 000 |