The following data is part of a premarket notification filed by Prizm Medical, Inc. with the FDA for 5000z Firefly System.
| Device ID | K133502 |
| 510k Number | K133502 |
| Device Name: | 5000Z FIREFLY SYSTEM |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | PRIZM MEDICAL, INC. 2888 FOREST RIDGE Chaska, MN 55318 |
| Contact | Carl Beaurline |
| Correspondent | James P. Johnson PRIZM MEDICAL, INC. 1236 DOKER DRIVE Modesto, CA 95351 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-14 |
| Decision Date | 2014-12-03 |
| Summary: | summary |