The following data is part of a premarket notification filed by Class A Enterprises, Inc. with the FDA for Low Profile Eeg Needle Electrode, Models 112-812-18tp, 112-812-48tp, 112-812-60tp, 112-812-72tp, 112-812-96tp, 112-812.
| Device ID | K023472 |
| 510k Number | K023472 |
| Device Name: | LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 |
| Classification | Electrode, Needle |
| Applicant | CLASS A ENTERPRISES, INC. P.O. BOX 401964-16039 WALNUT ST. STE C Hesperia, CA 92340 |
| Contact | Samantha L Draper |
| Correspondent | Samantha L Draper CLASS A ENTERPRISES, INC. P.O. BOX 401964-16039 WALNUT ST. STE C Hesperia, CA 92340 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-16 |
| Decision Date | 2003-03-18 |