510(k) K920937
K920937 is an FDA 510(k) premarket notification submitted by Trek Medical Products, Inc. for the device "COMPUTERIZED PUPIL". The FDA issued a decision of Substantially Equivalent on October 2, 1992. The device falls under product code HLG (Pupillometer, Ac-Powered), a Class I device regulated under 21 CFR 886.1700. Trek Medical Products, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1992
- Date Received
- February 27, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pupillometer, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.1700
- Review Panel
- OP
- Submission Type