510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K981725Substantially Equivalent

Optovent Respiratory Monitor Model Number Rr 9700

Optovent AB, Fort Lee NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981725 is the FDA 510(k) clearance record for OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700, a class II device, cleared for Optovent, Inc. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list 2 510(k) clearances for Optovent, Inc., from to . As of , FDA records show no recalls naming K981725.

Clearance record

Decision date
Received
(263 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Optovent, Inc. 1350 Fifteenth St., Fort Lee NJ
510(k) summary
Statement
Third party review
No

Clearances, product code BZQ

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