WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014— 510(k) K091853

Name: FDA 510(k) clearance K091853
Creator: U.S. Food and Drug Administration
Published: 2009-09-21

Substantially Equivalent

Nspire Health, Inc.

FDA 510(k) clearance K091853 for WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014, Substantially Equivalent on 2009-09-21. Applicant: Nspire Health, Inc.. Device class: 2.

Clearance details

Applicant: Nspire Health, Inc.
Product code: Code BZK
Device class: Class 2
Regulation: 21 CFR 868.1850
Advisory panel: Anesthesiology
Date received: 2009-06-23
Decision date: 2009-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longmont, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.