The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable Ep Needle Electrodes, Disposable Hypodermic Needle Electrodes.
| Device ID | K152984 |
| 510k Number | K152984 |
| Device Name: | Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable EP Needle Electrodes, Disposable Hypodermic Needle Electrodes |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | BIO PROTECH, INC. DONGHWA MEDICAL INSTRUMENT COMPLEX, 151-3, DONGHWAGONDAN-RO, MUNMAK-EUP Wonju-si, KR 220-801 |
| Contact | Daniel Woo |
| Correspondent | Kevin Han BIO PROTECH USA, INC. 2601 WALNUT AVE Tustin, CA 92780 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-09 |
| Decision Date | 2016-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809083944626 | K152984 | 000 |
| 18809083943421 | K152984 | 000 |
| 18809083943438 | K152984 | 000 |
| 18809083943445 | K152984 | 000 |
| 18809083943452 | K152984 | 000 |
| 18809083943469 | K152984 | 000 |
| 18809083944510 | K152984 | 000 |
| 18809083944527 | K152984 | 000 |
| 18809083944534 | K152984 | 000 |
| 18809083944541 | K152984 | 000 |
| 18809083944558 | K152984 | 000 |
| 18809083944565 | K152984 | 000 |
| 18809083944572 | K152984 | 000 |
| 18809083944589 | K152984 | 000 |
| 18809083944596 | K152984 | 000 |
| 18809083944602 | K152984 | 000 |
| 18809083944619 | K152984 | 000 |
| 18809083943414 | K152984 | 000 |