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NiteLynx PVDF Effort Sensor Disposable Belt, Pre-Cut

by Neurotronics, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817111021363 UDI-DI Date20 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
NiteLynx PVDF Effort Sensor
Generic Name
Home-use sleep apnoea recording system
Model / Ref / Catalog
Disposable Belt, Pre-Cut, S60246
Primary DI / UDI-DI
00817111021363
510(k) Number
FDA Product Code
SFK
GMDN Term
Home-use sleep apnoea recording system
Device Class
Class II
Regulation Number
882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251480)

Other devices from Neurotronics, LLC

See all devices from Neurotronics, LLC →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No