Holter Recorder
FDA 510(k) K822970 · Agilent Technologies
510(k) numberK822970
Submission
- Device name
- Holter Recorder
- Applicant
- Agilent Technologies
Mchenry, IL, US - Received
- October 8, 1982
- Decision date
- November 3, 1982
- 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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Questions and answers
When was Holter Recorder cleared by the FDA?
Holter Recorder (K822970) received a 510(k) decision of Substantially Equivalent on November 3, 1982, 26 days after the submission was received.
What is the product code of K822970?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.