Digital Holter Recorder
FDA 510(k) K942781 · Agilent Technologies
510(k) numberK942781
Submission
- Device name
- Digital Holter Recorder
- Applicant
- Agilent Technologies
Camarillo, CA, US - Received
- June 13, 1994
- Decision date
- January 24, 1995
- 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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Questions and answers
When was Digital Holter Recorder cleared by the FDA?
Digital Holter Recorder (K942781) received a 510(k) decision of Substantially Equivalent on January 24, 1995, 225 days after the submission was received.
What is the product code of K942781?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.