THE BERG RESUSCITATION APPARATUS— 510(k) K882833

Name: FDA 510(k) clearance K882833
Creator: U.S. Food and Drug Administration
Published: 1988-08-19

Substantially Equivalent

Hursch Ent., Inc.

FDA 510(k) clearance K882833 for THE BERG RESUSCITATION APPARATUS, Substantially Equivalent on 1988-08-19. Applicant: Hursch Ent., Inc.. Device class: 2.

Clearance details

Applicant: Hursch Ent., Inc.
Product code: Code BTL
Device class: Class 2
Regulation: 21 CFR 868.5925
Advisory panel: Anesthesiology
Date received: 1988-07-08
Decision date: 1988-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTL

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K221634 — Oxymag - Transport and Emergency Ventilator2023-05-24
K202219 — VORTRAN GO2VENT with PEEP Valve2021-02-11
K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag2020-11-20
K182956 — Puffin Lite Infant Resuscitation System2019-01-18

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.