CSS-60 Digital Heart Rate Meter
FDA 510(k) K780702 · Burdick Corp.
510(k) numberK780702
Submission
- Device name
- CSS-60 Digital Heart Rate Meter
- Applicant
- Burdick Corp.
Mchenry, IL, US - Received
- April 25, 1978
- Decision date
- May 19, 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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| K253388 | Sleepiz One+ (Model 2.5)DRT · Special | Sleepiz AG | 01/28/2026SE |
| K251364 | Sleepiz One+ (2.5)DRT · Special | Sleepiz AG | 07/29/2025SE |
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| K231733 | Neteera 130H-Plus Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 02/09/2024SE |
| 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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| K943959 | Eclipse 4 ElectrocardiographLOS · Traditional | 05/17/1995SE |
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| K941351 | Burdick PRO2 OximeterDQA · Traditional | 10/13/1994SE |
| K942438 | Altair 6100 Cassette RecorderDSH · Traditional | 08/05/1994SE |
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Questions and answers
When was CSS-60 Digital Heart Rate Meter cleared by the FDA?
CSS-60 Digital Heart Rate Meter (K780702) received a 510(k) decision of Substantially Equivalent on May 19, 1978, 24 days after the submission was received.
What is the product code of K780702?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.