The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Zen Wireless Footswitch (w1000), Zen Wireless Footswitch Adapter (w1100).
| Device ID | K083161 |
| 510k Number | K083161 |
| Device Name: | ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) |
| Classification | Arthroscope |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Sue Dauterman |
| Correspondent | Sue Dauterman CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-27 |
| Decision Date | 2009-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10845854850770 | K083161 | 000 |
| 10845854850312 | K083161 | 000 |
| 10845854050316 | K083161 | 000 |
| 10845854050934 | K083161 | 000 |
| 10845854050941 | K083161 | 000 |