510(k) K831898
K831898 is an FDA 510(k) premarket notification submitted by Dr. Micheal A. Sabia for the device "SCOLIMETER". The FDA issued a decision of Substantially Equivalent on July 19, 1983. The device falls under product code KTZ (Caliper), a Class I device regulated under 21 CFR 888.4150. Dr. Micheal A. Sabia has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1983
- Date Received
- June 14, 1983
- 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