Holter Performer Feather Weight/Cass
FDA 510(k) K833823 · Applied Cardiac Systems
510(k) numberK833823
Submission
- Device name
- Holter Performer Feather Weight/Cass
- Applicant
- Applied Cardiac Systems
Mchenry, IL, US - Received
- November 2, 1983
- Decision date
- December 1, 1983
- 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 Performer Feather Weight/Cass cleared by the FDA?
Holter Performer Feather Weight/Cass (K833823) received a 510(k) decision of Substantially Equivalent on December 1, 1983, 29 days after the submission was received.
What is the product code of K833823?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.