510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970694Substantially Equivalent

Model 1700, Hydro Prep

Physiometrix, Inc., North Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970694 is the FDA 510(k) clearance record for MODEL 1700, HYDRO PREP, a class II device, cleared for Physiometrix, Inc. on under FDA product code GYB (Media, Electroconductive). FDA records list 22 510(k) clearances for Physiometrix, Inc., from to . As of , FDA records show 3 recalls naming K970694.

Clearance record

Decision date
Received
(78 days to decision)
Product code
GYB Media, Electroconductive
Regulation
21 CFR 882.1275
Device class
Class II
Review panel
Neurology
Applicant
Physiometrix, Inc. Five Billerica Park,, North Billerica MA
510(k) summary
Summary
Third party review
No

Clearances, product code GYB

Trailing 12 months

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

FDA records show no clearances under product code GYB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GYB, 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