M1730B Tracemaster ECG System, M1766B Local Edit Station, M1798B Remote Edit Station
FDA 510(k) K974420 · Hewlett-Packard Co.
510(k) numberK974420
Submission
- Device name
- M1730B Tracemaster ECG System, M1766B Local Edit Station, M1798B Remote Edit Station
- Applicant
- Hewlett-Packard Co.
North Attleboro, MA, US - Received
- November 24, 1997
- Decision date
- February 19, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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Questions and answers
When was M1730B Tracemaster ECG System, M1766B Local Edit Station, M1798B Remote Edit Station cleared by the FDA?
M1730B Tracemaster ECG System, M1766B Local Edit Station, M1798B Remote Edit Station (K974420) received a 510(k) decision of Substantially Equivalent on February 19, 1998, 87 days after the submission was received.
What is the product code of K974420?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.