Model TTPM Time Temp. Pressure Monitor
FDA 510(k) K832897 · Electromedics, Inc.
510(k) numberK832897
Submission
- Device name
- Model TTPM Time Temp. Pressure Monitor
- Applicant
- Electromedics, Inc.
Walker, MI, US - Received
- August 22, 1983
- Decision date
- March 22, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRS – Transducer, Blood-Pressure, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2850
- Specialty
- Cardiovascular
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Questions and answers
When was Model TTPM Time Temp. Pressure Monitor cleared by the FDA?
Model TTPM Time Temp. Pressure Monitor (K832897) received a 510(k) decision of Substantially Equivalent on March 22, 1984, 213 days after the submission was received.
What is the product code of K832897?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.