FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL MICRO ST AMBULATORY ECG MONITOR
K Number: K870537
·
Decision Apr 23, 1987
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
14
Review Days
73
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Basic Information
- Device Name
- MODEL MICRO ST AMBULATORY ECG MONITOR
- K Number
- K870537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Advanced Medical Products, Inc.
- Date Received
- February 9, 1987
- Decision Date
- April 23, 1987
- 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 Advanced Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000932 | ARACHNOPHLEBECTOMY NEEDLE | May 17, 2000 | Substantially Equivalent |
| K923995 | URODYNAMICS TUBING KITS #5161, #5150, #7170 | Apr 8, 1993 | Substantially Equivalent |
| K921426 | ULTRA PCI | Oct 5, 1992 | Substantially Equivalent |
| K912925 | ULTRA PVD | Jun 18, 1992 | Substantially Equivalent |
| K915658 | SPECTRA ECG | Jun 10, 1992 | Substantially Equivalent |
| K896103 | MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR | Jan 18, 1990 | Substantially Equivalent |
| K896102 | MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR | Jan 18, 1990 | Substantially Equivalent |
| K881905 | MODEL MICRO SI AMBULATORY ECG MONITOR | Aug 2, 1988 | Substantially Equivalent |
| K872508 | MODEL MICRO FD+ AMBULATORY ECG MONITOR | Sep 25, 1987 | Substantially Equivalent |
| K870538 | MODEL 192 PRINTER | Apr 23, 1987 | Substantially Equivalent |