510(k) K874300
K874300 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "AESTHESIOMETER". The FDA issued a decision of Substantially Equivalent on November 6, 1987. The device falls under product code GWI (Discriminator, Two-Point), a Class I device regulated under 21 CFR 882.1200. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 1987
- Date Received
- October 20, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Discriminator, Two-Point
- Device Class
- Class I
- Regulation Number
- 882.1200
- Review Panel
- NE
- Submission Type