DMR PLUS DISPOSABLE MANUAL RESUSCITATOR— 510(k) K973419

Name: FDA 510(k) clearance K973419
Creator: U.S. Food and Drug Administration
Published: 1998-03-25

Substantially Equivalent

Nellcor Puritan Bennett, Inc.

FDA 510(k) clearance K973419 for DMR PLUS DISPOSABLE MANUAL RESUSCITATOR, Substantially Equivalent on 1998-03-25. Applicant: Nellcor Puritan Bennett, Inc.. Device class: 2.

Clearance details

Applicant: Nellcor Puritan Bennett, Inc.
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 1997-09-10
Decision date: 1998-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTM

view all

K251631 — The BAG manual resuscitator and accessories2025-11-24
K243861 — butterflyBVM2025-04-25
K221841 — EOlife®2023-03-18
K212905 — Sotair Device2022-08-18
K210288 — Disposable Manual Resuscitator2021-08-26

More clearances from Nellcor Puritan Bennett, Inc.

view all

K070408 — DURAMAX REUSABLE OXIMETRY SENSOR2007-05-25
K060576 — NELLCOR OXIMAX N-600X PULSE OXIMETER2006-08-14
K051271 — OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR2006-01-10
K052186 — NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P2005-11-10
K051352 — OXIMAX NPB-40 HANDHELD PULSE OXIMETER2005-08-11

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.