The following data is part of a premarket notification filed by Prizm Medical, Inc. with the FDA for 5000z System (otc).
| Device ID | K033122 |
| 510k Number | K033122 |
| Device Name: | 5000Z SYSTEM (OTC) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | PRIZM MEDICAL, INC. 5536 TROWBRIDGE DR. Dunwoody, GA 30338 |
| Contact | Cathryn N Cambria |
| Correspondent | Cathryn N Cambria PRIZM MEDICAL, INC. 5536 TROWBRIDGE DR. Dunwoody, GA 30338 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2004-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B872REVSTM20 | K033122 | 000 |
| B872SPZ2000 | K033122 | 000 |