The following data is part of a premarket notification filed by Jcm Management & Planning Co. with the FDA for Tcd Or Tcd Neuropathy Star.
| Device ID | K944234 |
| 510k Number | K944234 |
| Device Name: | TCD OR TCD NEUROPATHY STAR |
| Classification | Discriminator, Two-point |
| Applicant | JCM MANAGEMENT & PLANNING CO. 117 PARRISH LN. Wilmington, DE 19810 |
| Contact | Charles Laudadio |
| Correspondent | Charles Laudadio JCM MANAGEMENT & PLANNING CO. 117 PARRISH LN. Wilmington, DE 19810 |
| Product Code | GWI |
| CFR Regulation Number | 882.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-31 |
| Decision Date | 1995-03-08 |