FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SPECTRA ECG
K Number: K915658
·
Decision Jun 10, 1992
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
14
Review Days
175
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Basic Information
- Device Name
- SPECTRA ECG
- K Number
- K915658
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Medical Products, Inc.
- Date Received
- December 18, 1991
- Decision Date
- June 10, 1992
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.
Other Clearances by Advanced Medical Products, Inc.
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| K921426 | ULTRA PCI | Oct 5, 1992 | Substantially Equivalent |
| K912925 | ULTRA PVD | Jun 18, 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 |
| K870537 | MODEL MICRO ST AMBULATORY ECG MONITOR | Apr 23, 1987 | Substantially Equivalent |
| K870538 | MODEL 192 PRINTER | Apr 23, 1987 | Substantially Equivalent |