Zymed Holter Scanner Model 2010
FDA 510(k) K930806 · Agilent Technologies
510(k) numberK930806
Submission
- Device name
- Zymed Holter Scanner Model 2010
- Applicant
- Agilent Technologies
Camarillo, CA, US - Received
- February 16, 1993
- Decision date
- April 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was Zymed Holter Scanner Model 2010 cleared by the FDA?
Zymed Holter Scanner Model 2010 (K930806) received a 510(k) decision of Substantially Equivalent on April 25, 1994, 433 days after the submission was received.
What is the product code of K930806?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.