Holter Digicorder with Pacer Option (Model 483)
FDA 510(k) K963174 · Del Mar Avionics
510(k) numberK963174
Submission
- Device name
- Holter Digicorder with Pacer Option (Model 483)
- Applicant
- Del Mar Avionics
Irvine, CA, US - Received
- August 14, 1996
- Decision date
- March 13, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K922221 | Sprint DX, Model 5400 Exercise Stress Test SystemLOS · Traditional | 04/21/1993SE |
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| 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 |
| K884887 | Model 499 SSR Analysis SystemDSI · Traditional | 02/06/1989SE |
Questions and answers
When was Holter Digicorder with Pacer Option (Model 483) cleared by the FDA?
Holter Digicorder with Pacer Option (Model 483) (K963174) received a 510(k) decision of Substantially Equivalent on March 13, 1997, 211 days after the submission was received.
What is the product code of K963174?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.