Vasomedical Biox CB-1305-C, 3 Channel ECG Holter Monitor, Model CB-1305-C
FDA 510(k) K083820 · Vasomedical, Inc.
510(k) numberK083820
Submission
- Device name
- Vasomedical Biox CB-1305-C, 3 Channel ECG Holter Monitor, Model CB-1305-C
- Applicant
- Vasomedical, Inc.
Westbury, NY, US - Received
- December 22, 2008
- Decision date
- April 1, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K033617 | Eecp Therapy System Model TS4 With/Without Pluse OximetryDRN · Traditional | 03/01/2004SE |
| K020857 | Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation…DRN · Traditional | 06/14/2002SE |
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Questions and answers
When was Vasomedical Biox CB-1305-C, 3 Channel ECG Holter Monitor, Model CB-1305-C cleared by the FDA?
Vasomedical Biox CB-1305-C, 3 Channel ECG Holter Monitor, Model CB-1305-C (K083820) received a 510(k) decision of Substantially Equivalent on April 1, 2009, 100 days after the submission was received.
What is the product code of K083820?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.