Diffusion System, Single-Breath (47404A)
FDA 510(k) K760169 · Hewlett-Packard Co.
510(k) numberK760169
Submission
- Device name
- Diffusion System, Single-Breath (47404A)
- Applicant
- Hewlett-Packard Co.
Mchenry, IL, US - Received
- July 6, 1976
- Decision date
- July 20, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1430
- Specialty
- Anesthesiology
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Questions and answers
When was Diffusion System, Single-Breath (47404A) cleared by the FDA?
Diffusion System, Single-Breath (47404A) (K760169) received a 510(k) decision of Substantially Equivalent on July 20, 1976, 14 days after the submission was received.
What is the product code of K760169?
The FDA product code is CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1430.