Cadio-Respiratory Monitor #CR-2
FDA 510(k) K823312 · Electromed Intl., Ltd.
510(k) numberK823312
Submission
- Device name
- Cadio-Respiratory Monitor #CR-2
- Applicant
- Electromed Intl., Ltd.
Walker, MI, US - Received
- November 5, 1982
- Decision date
- November 30, 1982
- 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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| K223163 | Sleepiz One+DRT · Traditional | Sleepiz AG | 08/18/2023SE |
| K212143 | Neteera 130H/131H Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 09/28/2022SE |
| K202138 | Cardiac Trigger MonitorDRT · Traditional | Ivy Biomedical Systems, Inc. | 05/14/2021SE |
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Questions and answers
When was Cadio-Respiratory Monitor #CR-2 cleared by the FDA?
Cadio-Respiratory Monitor #CR-2 (K823312) received a 510(k) decision of Substantially Equivalent on November 30, 1982, 25 days after the submission was received.
What is the product code of K823312?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.