The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Nicolet Disposable Prass Probe.
Device ID | K873964 |
510k Number | K873964 |
Device Name: | NICOLET DISPOSABLE PRASS PROBE |
Classification | Stimulator, Nerve |
Applicant | NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711 |
Contact | Raymond T Riddle |
Correspondent | Raymond T Riddle NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711 |
Product Code | ETN |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-29 |
Decision Date | 1987-11-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20643169938438 | K873964 | 000 |
00763000416997 | K873964 | 000 |
00763000417000 | K873964 | 000 |
00763000417024 | K873964 | 000 |
00763000417031 | K873964 | 000 |
00763000417048 | K873964 | 000 |
00763000417055 | K873964 | 000 |
00763000417062 | K873964 | 000 |
20763000038414 | K873964 | 000 |
00681490038584 | K873964 | 000 |
20643169431120 | K873964 | 000 |
20643169938360 | K873964 | 000 |
00763000842567 | K873964 | 000 |