510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K982550Substantially Equivalent - Subject to Tracking Reg.

Browser (Event Software) Model # 4500E

Respironics, Inc., Pittsburgh PA / Traditional, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K982550 is the FDA 510(k) clearance record for BROWSER (EVENT SOFTWARE) MODEL # 4500E, a class II device, cleared for Respironics, Inc. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K982550.

Clearance record

Decision date
Received
(75 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Respironics, Inc. 1501 Ardmore Blvd., Pittsburgh PA
Third party review
No

Clearances, product code BZQ

Trailing 12 months
2 clearances under product code BZQ in the twelve months to November 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZQ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260
November 20260