510(k) K944234
K944234 is an FDA 510(k) premarket notification submitted by Jcm Management & Planning Co. for the device "TCD OR TCD NEUROPATHY STAR". The FDA issued a decision of Substantially Equivalent on March 8, 1995. The device falls under product code GWI (Discriminator, Two-Point), a Class I device regulated under 21 CFR 882.1200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1995
- Date Received
- August 31, 1994
- 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