Monitor, Patient, Model PM-20N
FDA 510(k) K770736 · Cavitron Corp.
510(k) numberK770736
Submission
- Device name
- Monitor, Patient, Model PM-20N
- Applicant
- Cavitron Corp.
Mchenry, IL, US - Received
- April 21, 1977
- Decision date
- June 2, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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Questions and answers
When was Monitor, Patient, Model PM-20N cleared by the FDA?
Monitor, Patient, Model PM-20N (K770736) received a 510(k) decision of Substantially Equivalent on June 2, 1977, 42 days after the submission was received.
What is the product code of K770736?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.