Home / 510(k) Clearances / K221555

510(k) K221555

Dozee VS by Turtle Shell Technologies Private Limited — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2022
Date Received
May 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances for product code BZQ

  • K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (September 26, 2025)
  • K250934 — Respiree Cardio- Respiratory Monitor System (August 5, 2025)
  • K243183 — RTMsense Respiratory Monitoring System (June 27, 2025)
  • K243966 — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (April 9, 2025)
  • K242001 — Philips VSC-MEDlib (April 4, 2025)
  • K233953 — Makani Science™ Respiration Monitoring System (March 28, 2025)
  • K242798 — Airmod (February 28, 2025)
  • K240271 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (September 11, 2024)
  • K223681 — Respiree Cardio-Respiratory Monitor (March 8, 2023)
  • K223246 — Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense (November 18, 2022)