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 |