Infant Caridac Monitor
FDA 510(k) K812674 · Electromed Intl., Ltd.
510(k) numberK812674
Submission
- Device name
- Infant Caridac Monitor
- Applicant
- Electromed Intl., Ltd.
Mchenry, IL, US - Received
- September 22, 1981
- Decision date
- October 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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| K202138 | Cardiac Trigger MonitorDRT · Traditional | Ivy Biomedical Systems, Inc. | 05/14/2021SE |
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Questions and answers
When was Infant Caridac Monitor cleared by the FDA?
Infant Caridac Monitor (K812674) received a 510(k) decision of Substantially Equivalent on October 13, 1981, 21 days after the submission was received.
What is the product code of K812674?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.