510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K073656Substantially Equivalent

Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System

Hypermed, Inc., Winchester MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073656 is the FDA 510(k) clearance record for OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM, a class II device, cleared for Hypermed, Inc. on under FDA product code MUD (Oximeter, Tissue Saturation). FDA records list 2 510(k) clearances for Hypermed, Inc., from to . As of , FDA records show no recalls naming K073656.

Clearance record

Decision date
Received
(30 days to decision)
Product code
MUD Oximeter, Tissue Saturation
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Hypermed, Inc. 11 Mystic Ave., Winchester MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUD

Trailing 12 months
1 clearance under product code MUD in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MUD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260