The following data is part of a premarket notification filed by Anesthesia Assoc., Inc. with the FDA for Nerve Stimulator Model Aa 1050.
Device ID | K811614 |
510k Number | K811614 |
Device Name: | NERVE STIMULATOR MODEL AA 1050 |
Classification | Stimulator, Nerve, Battery-powered |
Applicant | ANESTHESIA ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BXN |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-08 |
Decision Date | 1981-06-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B00500112P0 | K811614 | 000 |
B00500110P0 | K811614 | 000 |
B005001090 | K811614 | 000 |
B00500108P0 | K811614 | 000 |
B00500107P0 | K811614 | 000 |
B005001060 | K811614 | 000 |
B00500100PLUSKIT0 | K811614 | 000 |
B00500100PLUSDEMO0 | K811614 | 000 |
B00500100PLUS0 | K811614 | 000 |