Informed Remote Field Unit Model IFM1000
FDA 510(k) K821712 · Burditt & Calkins-Siemens-Elema
510(k) numberK821712
Submission
- Device name
- Informed Remote Field Unit Model IFM1000
- Applicant
- Burditt & Calkins-Siemens-Elema
Mchenry, IL, US - Received
- June 9, 1982
- Decision date
- July 26, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTY – Calculator, Predicted Values, Pulmonary Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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Questions and answers
When was Informed Remote Field Unit Model IFM1000 cleared by the FDA?
Informed Remote Field Unit Model IFM1000 (K821712) received a 510(k) decision of Substantially Equivalent on July 26, 1982, 47 days after the submission was received.
What is the product code of K821712?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.