Inspiron Pulmonary Function Analyzer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K802920 FDA 510(k)
- FDA Product Code
- BZC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1880 FDA 510(k)
- Regulation Number
- 868.1880 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Inspiron Pulmonary Function Analyzer is a Class II medical device classified as a Calculator, Pulmonary Function Data (product code BZC). It is designed to measure and analyze pulmonary function parameters, providing quantitative data for respiratory assessment.
This device is intended for use in clinical settings, including anesthesia and pulmonary care environments. Supplied as a reusable instrument, it operates under regulatory oversight as per FDA 510(k) clearance (K802920) and adheres to the special controls outlined in regulation number 868.1880. No sterility or single-use specifications are indicated in the available data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: INSPIRON PULMONARY FUNCTION ANALYZER (K802920) — FDA 510 (k) | Innolitics, INSPIRON PULMONARY FUNCTION ANALYZER (K802920) - FDA 510 (k), Inspiron Pulmonary Function Analyzer 510(k) K802920 - FDA.report, PDF K802920 - Inspiron Pulmonary Function Analyzer
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K802920 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K802920 24 fields · synced Sep 18, 2026