The following data is part of a premarket notification filed by Digitcare Corp. with the FDA for Digitcare I.v. Start Kit.
| Device ID | K905009 |
| 510k Number | K905009 |
| Device Name: | DIGITCARE I.V. START KIT |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | DIGITCARE CORP. 300 S. BEVERLY DR. Beverly Hils, CA 90212 |
| Contact | Michael Wool |
| Correspondent | Michael Wool DIGITCARE CORP. 300 S. BEVERLY DR. Beverly Hils, CA 90212 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1990-12-18 |