The following data is part of a premarket notification filed by Selfcare, Inc. with the FDA for Fasttake Adapter, Model # P/n 020-072-01.
| Device ID | K983468 |
| 510k Number | K983468 |
| Device Name: | FASTTAKE ADAPTER, MODEL # P/N 020-072-01 |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | SELFCARE, INC. 200 PROSPECT ST. Waltham, MA 02154 -3457 |
| Contact | Betty Lane |
| Correspondent | Betty Lane SELFCARE, INC. 200 PROSPECT ST. Waltham, MA 02154 -3457 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-01 |
| Decision Date | 1998-12-17 |
| Summary: | summary |