510(k) K832989
K832989 is an FDA 510(k) premarket notification submitted by Bcsi Laboratories, Inc. for the device "BREAST THERMAL ACTIVITY INDICATOR". The FDA issued a decision of Substantially Equivalent on January 17, 1984. The device falls under product code KYA (System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2982.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1984
- Date Received
- September 1, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
- Device Class
- Class I
- Regulation Number
- 884.2982
- Review Panel
- RA
- Submission Type