510(k) K813315
K813315 is an FDA 510(k) premarket notification submitted by Design Research Assoc., Inc. for the device "CALIPER-OPTHALMIC". The FDA issued a decision of Substantially Equivalent on March 1, 1982. The device falls under product code HOE (Caliper, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Design Research Assoc., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1982
- Date Received
- November 24, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Caliper, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type