510(k) K801907
K801907 is an FDA 510(k) premarket notification submitted by Rowan Products, Inc. for the device "ALGESIOMETER". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code GXB (Esthesiometer), a Class I device regulated under 21 CFR 882.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 1980
- Date Received
- August 11, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esthesiometer
- Device Class
- Class I
- Regulation Number
- 882.1500
- Review Panel
- NE
- Submission Type