510(k) K821082
K821082 is an FDA 510(k) premarket notification submitted by Medical Equipment Designs, Inc. for the device "TRIAL LENS SET". The FDA issued a decision of Substantially Equivalent on Jun 14, 1982. The device falls under product code HLH (Pupillometer, Manual), a Class I device regulated under 21 CFR 886.1700. Medical Equipment Designs, Inc. has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 14, 1982
- Date Received
- Apr 19, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pupillometer, Manual
- Device Class
- Class I
- Regulation Number
- 886.1700
- Review Panel
- OP
- Submission Type
- 510(k) Exempt