510(k) K930962
K930962 is an FDA 510(k) premarket notification submitted by Capintec Instruments, Inc. for the device "CAPTUS 2000 WEL COUNTER". The FDA issued a decision of Substantially Equivalent on May 18, 1993. The device falls under product code IZD (Probe, Uptake, Nuclear), a Class I device regulated under 21 CFR 892.1320. Capintec Instruments, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1993
- Date Received
- February 24, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Uptake, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1320
- Review Panel
- RA
- Submission Type