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

Monitor, Apnea, Facility Use

21 CFR 868.2377 / Anesthesiology
FDA source (opens on fda.gov)

FLS is the FDA product code for Monitor, Apnea, Facility Use, a class II device type, regulated under 21 CFR 868.2377. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FLS
Device name
Monitor, Apnea, Facility Use
Regulation
21 CFR 868.2377
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
16
Ingested recalls
2

Clearances, product code FLS

By decision year
16 clearances under product code FLS with a decision year between 1976 and 2002, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FLS by decision year
YearClearances
19762
19781
19802
19811
19823
19831
19841
19891
19962
20001
20021

Applicants with the most clearances

Product code FLS
Applicants holding the most 510(k) clearances under product code FLS
ApplicantClearances
Air-Shields, Inc.1
Airsep Corp.1
Alternative Design Systems, Inc.1
Burr Engineering & Development Co.1
Clinical Data, Inc.1
Douglas Scientific Products1
Hogan & Hartson1
Ilife Systems, Inc.1
Litton Medical Electronics1
Med Dyne Inst., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code