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510(k) K771175

RESUSCITATOR, MS30 by Mckesson Corp. — Product Code BTM

K771175 is an FDA 510(k) premarket notification submitted by Mckesson Corp. for the device "RESUSCITATOR, MS30". The FDA issued a decision of Substantially Equivalent on August 2, 1977. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Mckesson Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1977
Date Received
June 29, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances by Mckesson Corp.

  • K761196 — NITROUS OXIDE SCAVENGING MASK (December 13, 1976)
  • K761195 — ESOPHAGEAL OBTURATION AIRWAY (December 9, 1976)
  • K761194 — HLR QUICK-FIT HEART-LUNG RESUSCITATOR (December 9, 1976)
  • K760017 — CONSIOUS SEDATION (ANALOR P-76) (July 20, 1976)

Other clearances for product code BTM

  • K251631 — The BAG manual resuscitator and accessories (November 24, 2025)
  • K243861 — butterflyBVM (April 25, 2025)
  • K221841 — EOlife® (March 18, 2023)
  • K212905 — Sotair Device (August 18, 2022)
  • K210288 — Disposable Manual Resuscitator (August 26, 2021)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)

FDA data resources