Identifiers
- 510(k) Number
- K781838 FDA 510(k)
- FDA Product Code
- BWF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5690 FDA 510(k)
- Regulation Number
- 868.5690 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Spirometer, Therapeutic (Incentive) as defined by the FDA product code BWF. It is a calculator with charger intended for use in respiratory therapy to measure and encourage patient breathing effort.
It was cleared by the FDA through the 510(k) process (K781838) on November 21, 1978, and is classified as a Class II device under special controls. The device was submitted by C.R. Bard, Inc. of McHenry, Illinois, and is used in the anesthesiology specialty setting.
Frequently asked questions
What is the Calculator, With Charger used for?
It is used as a therapeutic incentive spirometer to measure and encourage patient breathing effort during respiratory therapy, particularly in anesthesiology settings, to support lung expansion and prevent postoperative complications.
How is the Calculator, With Charger supplied and powered?
The device includes a built-in calculator and is supplied with a charger, indicating it is designed for repeated use with rechargeable power, allowing consistent operation in clinical environments without reliance on disposable batteries.
Is the Calculator, With Charger a single-use or reusable device?
It is a reusable device, as it incorporates a charger for repeated use, and its design as a calculator with charging capability indicates it is intended for multiple patient encounters over time, not disposal after a single use.
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: CALCULATOR, WITH CHARGER (K781838) — FDA 510(k) | Innolitics, CALCULATOR, WITH CHARGER (K781838) - FDA 510 (k), SolveCalc - Free CalcSolver with Code Mode | Math Solver, PDF K781838 CALCULATOR, WITH CHARGER - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K781838 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K781838 24 fields · synced Oct 1, 2026