FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORTHEAST MONITORING DR180
K Number: K960925
·
Decision Jul 31, 1996
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
10
Review Days
147
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Basic Information
- Device Name
- NORTHEAST MONITORING DR180
- K Number
- K960925
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- North East Monitoring, Inc.
- Date Received
- March 6, 1996
- Decision Date
- July 31, 1996
- 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 North East Monitoring, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142424 | DR300 HOLTER MONITOR | Nov 25, 2014 | Substantially Equivalent |
| K081861 | HOLTER LX ANALYSIS | Dec 4, 2008 | Substantially Equivalent |
| K070014 | AUTO DETECT FOR TELAHEART DR200/E-A | May 25, 2007 | Substantially Equivalent |
| K061293 | TELAHEART DIGITAL RECORDER | Aug 25, 2006 | Substantially Equivalent |
| K041901 | SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER | Aug 31, 2004 | Substantially Equivalent |
| K004007 | DR180+OXY | Jan 25, 2001 | Substantially Equivalent |
| K001288 | DR180-II | Jul 20, 2000 | Substantially Equivalent |
| K983576 | DR180-R/OXY | Mar 23, 1999 | Substantially Equivalent |
| K930564 | HOLTER FOR WINDOWS | Apr 19, 1995 | Substantially Equivalent |