Calculator, with Charger
FDA 510(k) K781838 · C.R. Bard, Inc.
510(k) numberK781838
Submission
- Device name
- Calculator, with Charger
- Applicant
- C.R. Bard, Inc.
Mchenry, IL, US - Received
- October 27, 1978
- Decision date
- November 21, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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Questions and answers
When was Calculator, with Charger cleared by the FDA?
Calculator, with Charger (K781838) received a 510(k) decision of Substantially Equivalent on November 21, 1978, 25 days after the submission was received.
What is the product code of K781838?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.