510(k) K823679
K823679 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "NML 6000 CT". The FDA issued a decision of Substantially Equivalent on January 7, 1983. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Nuclear Medical Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1983
- Date Received
- December 7, 1982
- 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