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

Respiratory Effort Belt For Polysomnography

21 CFR 882.1400 / Neurology
FDA source (opens on fda.gov)

SFK is the FDA product code for Respiratory Effort Belt For Polysomnography, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "To assess respiratory/breathing effort by measuring the movement of chest and abdominal walls. The belts function as accessories to sleep/polysomnography (PSG) and home sleep apnea test (HSAT) systems". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SFK
Device name
Respiratory Effort Belt For Polysomnography
FDA definition
To assess respiratory/breathing effort by measuring the movement of chest and abdominal walls. The belts function as accessories to sleep/polysomnography (PSG) and home sleep apnea test (HSAT) systems.
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SFK

By decision year
1 clearance under product code SFK with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SFK by decision year
YearClearances
20251

Applicants with the most clearances

Product code SFK
Applicants holding the most 510(k) clearances under product code SFK
ApplicantClearances
Neurotronics, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code