510(k) K881515
K881515 is an FDA 510(k) premarket notification submitted by Visionex, Inc. for the device "TEAR VOLUME TESTS". The FDA issued a decision of Substantially Equivalent on May 23, 1988. The device falls under product code KYD (Strip, Schirmer), a Class I device regulated under 21 CFR 886.1800. Visionex, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1988
- Date Received
- April 11, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strip, Schirmer
- Device Class
- Class I
- Regulation Number
- 886.1800
- Review Panel
- OP
- Submission Type