The following data is part of a premarket notification filed by B & L Engineering with the FDA for B & L Electrode.
| Device ID | K952655 |
| 510k Number | K952655 |
| Device Name: | B & L ELECTRODE |
| Classification | Electromyograph, Diagnostic |
| Applicant | B & L ENGINEERING 12309 EAST FLORENCE AVE. Santa Fe Springs, CA 90670 |
| Contact | Lee A Barnes |
| Correspondent | Lee A Barnes B & L ENGINEERING 12309 EAST FLORENCE AVE. Santa Fe Springs, CA 90670 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1995-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855144007077 | K952655 | 000 |
| 00855144007060 | K952655 | 000 |
| 00855144007046 | K952655 | 000 |