FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DYNAMIC SPECTRAL PHONOCARDIOGRAPH
K Number: K902185
·
Decision Mar 25, 1991
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
17
Applicant Total
1
Review Days
315
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Basic Information
- Device Name
- DYNAMIC SPECTRAL PHONOCARDIOGRAPH
- K Number
- K902185
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Reeves Scientific, Inc.
- Date Received
- May 14, 1990
- Decision Date
- March 25, 1991
- Product Code
- DQC
- 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 |
|---|---|---|---|
| DQC | Phonocardiograph | FDA class 1 | Cardiovascular |
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