DIGITAL HEART RATE METER
FDA 510(k) clearance K770239 · decided 1977-02-14
Clearance details
- K-number
- K770239
- Device name
- DIGITAL HEART RATE METER
- Applicant
- Burdick Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-02-07
- Decision date
- 1977-02-14
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- DRT
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| Sleepiz One+ (K223163) | Sleepiz AG | 2023-08-18 |
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| Cardiac Trigger Monitor (K202138) | Ivy Biomedical Systems, Inc. | 2021-05-14 |
| Vital Sign Monitoring Sensor (Model :XK300) (K202464) | Xandar Kardian, Inc. | 2021-04-26 |
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Recalls involving this device
No recalls on record reference this clearance.