FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
K Number: K111096
·
Decision Jun 24, 2011
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
7
Review Days
65
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Basic Information
- Device Name
- VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
- K Number
- K111096
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vasomedical, Inc.
- Date Received
- April 20, 2011
- Decision Date
- June 24, 2011
- Product Code
- DSH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Vasomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111180 | VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY | Jun 28, 2011 | Substantially Equivalent |
| K092785 | COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 | Apr 2, 2010 | Substantially Equivalent |
| K083820 | VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C | Apr 1, 2009 | Substantially Equivalent |
| K033617 | EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY | Mar 1, 2004 | Substantially Equivalent |
| K020857 | EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER | Jun 14, 2002 | Substantially Equivalent |
| K003469 | EECP THERAPY SYSTEM, MODEL TS3 | Dec 6, 2000 | Substantially Equivalent |