510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011597Substantially Equivalent

Smartmonitor 2, Model 4000

Respironics Georgia, Inc., Kennesaw GA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K011597 is the FDA 510(k) clearance record for SMARTMONITOR 2, MODEL 4000, a class II device, cleared for Respironics Georgia, Inc. on under FDA product code FLS (Monitor, Apnea, Facility Use). FDA records list 2 510(k) clearances for Respironics Georgia, Inc., from to . As of , FDA records show 2 recalls naming K011597.

Clearance record

Decision date
Received
(232 days to decision)
Product code
FLS Monitor, Apnea, Facility Use
Regulation
21 CFR 868.2377
Device class
Class II
Review panel
Anesthesiology
Applicant
Respironics Georgia, Inc. 175 Chastain Meadows Ct., Kennesaw GA
510(k) summary
Summary
Third party review
No

Clearances, product code FLS

Trailing 12 months

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

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