Monitor, Cardiac, Bedside
FDA 510(k) K772332 · Telectronics, Inc.
510(k) numberK772332
Submission
- Device name
- Monitor, Cardiac, Bedside
- Applicant
- Telectronics, Inc.
Mchenry, IL, US - Received
- December 22, 1977
- Decision date
- February 13, 1978
- 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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| K884411 | Optima MPT and SPT PacemakersDXY · Traditional | 01/26/1989SE |
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| K881837 | Optima MPT Series III Pacemaker, 5281D and 5282DDXY · Traditional | 07/18/1988SE |
| K874664 | Implantable Electrode Lead, Model 030-446DTB · Traditional | 05/31/1988SE |
| K864712 | Model 1740 Personal Pocket ProgrammerKRG · Traditional | 12/17/1987SE |
| K872766 | Implantable Programmable Cardiac Pulse GeneratorsDXY · Traditional | 11/04/1987SE |
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Questions and answers
When was Monitor, Cardiac, Bedside cleared by the FDA?
Monitor, Cardiac, Bedside (K772332) received a 510(k) decision of Substantially Equivalent on February 13, 1978, 53 days after the submission was received.
What is the product code of K772332?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.