510(k) K930575
K930575 is an FDA 510(k) premarket notification submitted by Bova Intl. for the device "KAMPPETER ANOMALOSCOPE". The FDA issued a decision of Substantially Equivalent on February 25, 1994. The device falls under product code HIW (Anomaloscope), a Class I device regulated under 21 CFR 886.1070. Bova Intl. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1994
- Date Received
- February 4, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anomaloscope
- Device Class
- Class I
- Regulation Number
- 886.1070
- Review Panel
- OP
- Submission Type