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510(k) K242424

Bluebird Single-Use Respiratory Effort Belt by Cadwell Industries, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2024
Date Received
August 15, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Cadwell Industries, Inc.

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  • K192624 — ApneaTrak (February 20, 2020)
  • K190760 — Cadwell Bolt Software (November 23, 2019)
  • K181466 — Cadwell Zenith System (September 1, 2018)
  • K180269 — Cadwell Apollo System (July 17, 2018)
  • K162199 — Cascade IOMAX Intraoperative Monitor (March 2, 2017)
  • K162383 — Cadwell Sierra Summit, Cadwell Sierra Ascent (March 1, 2017)
  • K161027 — Cadwell AmpliScan (November 8, 2016)

Other clearances for product code MNR

  • K252497 — SANSA HSAT (December 10, 2025)
  • K250882 — SANSA HSAT (October 29, 2025)
  • K250460 — WatchPAT400 (WP400) (September 5, 2025)
  • K252383 — Somfit D (August 28, 2025)
  • K243220 — Onera STS 2 (ONERA STS 2) (July 3, 2025)
  • K242224 — Happy Health Home Sleep Test (June 18, 2025)
  • K243092 — AcuPebble Ox (200) (March 19, 2025)
  • K243268 — TipTraQ (TTQ001) (February 3, 2025)
  • K244027 — SANSA HSAT (January 28, 2025)
  • K242290 — DormoTech NLab (January 8, 2025)