Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302, Vasomedical-Biox Ambulatory
FDA 510(k) K111096 · Vasomedical, Inc.
510(k) numberK111096
Submission
- Device name
- Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302, Vasomedical-Biox Ambulatory
- Applicant
- Vasomedical, Inc.
Westbury, NY, US - Received
- April 20, 2011
- Decision date
- June 24, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302, Vasomedical-Biox Ambulatory cleared by the FDA?
Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302, Vasomedical-Biox Ambulatory (K111096) received a 510(k) decision of Substantially Equivalent on June 24, 2011, 65 days after the submission was received.
What is the product code of K111096?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.