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
K033999Substantially Equivalent

Sedline with Frontal Psi

Physiometrix, Inc., North Billerica MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033999 is the FDA 510(k) clearance record for SEDLINE WITH FRONTAL PSI, a class II device, cleared for Physiometrix, Inc. on under FDA product code OLW (Index-Generating Electroencephalograph Software). FDA's definition for product code OLW reads: "Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user". FDA records list 22 510(k) clearances for Physiometrix, Inc., from to . As of , FDA records show no recalls naming K033999.

Clearance record

Decision date
Received
(44 days to decision)
Product code
OLW Index-Generating Electroencephalograph Software
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Physiometrix, Inc. Five Billerica Park,, North Billerica MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLW

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