510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K930575Substantially Equivalent

Kamppeter Anomaloscope

Bova Intl., Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930575 is the FDA 510(k) clearance record for KAMPPETER ANOMALOSCOPE, a class I device, cleared for Bova Intl. on under FDA product code HIW (Anomaloscope). FDA records list 2 510(k) clearances for Bova Intl., from to . As of , FDA records show no recalls naming K930575.

Clearance record

Decision date
Received
(386 days to decision)
Product code
HIW Anomaloscope
Regulation
21 CFR 886.1070
Device class
Class I
Review panel
Ophthalmic
Applicant
Bova Intl. 2217 Sixth Ave., Fort Worth TX
510(k) summary
Statement
Third party review
No

Clearances, product code HIW

Trailing 12 months

FDA records hold no clearances under product code HIW in the trailing twelve months.

FDA records show no clearances under product code HIW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HIW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260