510(k) K913510
K913510 is an FDA 510(k) premarket notification submitted by Pin Dot Products, Inc. for the device "MECHANICAL SHAPE SENSOR". The FDA issued a decision of Substantially Equivalent on September 23, 1991. The device falls under product code JFC (System, Pressure Measurement, Intermittent), a Class I device regulated under 21 CFR 890.1600. Pin Dot Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1991
- Date Received
- August 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Pressure Measurement, Intermittent
- Device Class
- Class I
- Regulation Number
- 890.1600
- Review Panel
- PM
- Submission Type