510(k) K921266
K921266 is an FDA 510(k) premarket notification submitted by Nk Biotechnical Engineering Co. for the device "NK MEDICAL MICROMETER, MODEL MC001". The FDA issued a decision of Substantially Equivalent on July 14, 1992. The device falls under product code KTZ (Caliper), a Class I device regulated under 21 CFR 888.4150. Nk Biotechnical Engineering Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1992
- Date Received
- March 16, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Caliper
- Device Class
- Class I
- Regulation Number
- 888.4150
- Review Panel
- OR
- Submission Type