BIRD (IPV) NONCONTINUOUS VENTILATORS— 510(k) K895485

Name: FDA 510(k) clearance K895485
Creator: U.S. Food and Drug Administration
Published: 1989-10-30

Substantially Equivalent

Percussionaire Corp.

FDA 510(k) clearance K895485 for BIRD (IPV) NONCONTINUOUS VENTILATORS, Substantially Equivalent on 1989-10-30. Applicant: Percussionaire Corp.. Device class: 2.

Clearance details

Applicant: Percussionaire Corp.
Product code: Code NHJ
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 1989-09-11
Decision date: 1989-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandpoint, ID, US

Download summary PDF View on FDA.gov ↗

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K905234 — TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES1991-06-13
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K905236 — IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES1991-04-18
K900313 — PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN1990-10-26
K900314 — PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN1990-10-26

Adverse events under product code NHJ

product code NHJ

Death: 7
Total: 7

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.