Model 447 Electrocardiocorder
FDA 510(k) K792079 · Del Mar Avionics
510(k) numberK792079
Submission
- Device name
- Model 447 Electrocardiocorder
- Applicant
- Del Mar Avionics
Mchenry, IL, US - Received
- October 15, 1979
- Decision date
- December 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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| K990027 | Omnicorder, Model 464DSH · Abbreviated | 02/09/1999SE |
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| K963174 | Holter Digicorder with Pacer Option (Model 483)DSH · Traditional | 03/13/1997SE |
| K950020 | Holter Pacercorder(R)DSH · Traditional | 08/17/1995SE |
| K942653 | Holter SSR Digicorder(Tm)DSH · Traditional | 05/10/1995SE |
| K922221 | Sprint DX, Model 5400 Exercise Stress Test SystemLOS · Traditional | 04/21/1993SE |
| K896862 | Model 263 Spectrascan(Tm) Holter Analysis SystemDSI · Traditional | 04/18/1990SE |
| K895793 | Micropotential Analyzer/Spectrocardiography OptionDSH · Traditional | 02/13/1990SE |
| K894543 | Model 493 SSR-3 Three Channel Solid-State RecorderDSI · Traditional | 02/08/1990SE |
| K891148 | Model 152 Delta Holter ECG Analysis SystemDSI · Traditional | 05/11/1989SE |
Questions and answers
When was Model 447 Electrocardiocorder cleared by the FDA?
Model 447 Electrocardiocorder (K792079) received a 510(k) decision of Substantially Equivalent on December 27, 1979, 73 days after the submission was received.
What is the product code of K792079?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.