510(k) K983468

FASTTAKE ADAPTER, MODEL # P/N 020-072-01 by Selfcare, Inc. — Product Code JQP

K983468 is an FDA 510(k) premarket notification submitted by Selfcare, Inc. for the device "FASTTAKE ADAPTER, MODEL # P/N 020-072-01". The FDA issued a decision of Substantially Equivalent on Dec 17, 1998. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Selfcare, Inc. has 14 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 17, 1998
Date Received
Oct 1, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Calculator/Data Processing Module, For Clinical Use
Device Class
Class I
Regulation Number
862.2100
Review Panel
CH
Submission Type
510(k) Exempt

Source: FDA 510(k) database entry for K983468. Report a data issue: hello@regdatalab.com.