The following data is part of a premarket notification filed by Professional Instruments Co. with the FDA for Model Ns-3cc Neuro-stim Peripheral Nerve Stimulat.
Device ID | K864829 |
510k Number | K864829 |
Device Name: | MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT |
Classification | Stimulator, Nerve, Battery-powered |
Applicant | PROFESSIONAL INSTRUMENTS CO. 10920 KINGHURST P.O. BOX 36221 Houston, TX 77099 |
Contact | Alfred C Coats |
Correspondent | Alfred C Coats PROFESSIONAL INSTRUMENTS CO. 10920 KINGHURST P.O. BOX 36221 Houston, TX 77099 |
Product Code | BXN |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-09 |
Decision Date | 1987-01-12 |