FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSCILLOMETRIC PULSE DETECTION DEVICE
K Number: K902453
·
Decision Aug 23, 1990
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
147
Applicant Total
6
Review Days
83
Basic Information
- Device Name
- OSCILLOMETRIC PULSE DETECTION DEVICE
- K Number
- K902453
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- THOMAS J. FOGARTY, M.D.
- Date Received
- June 1, 1990
- Decision Date
- August 23, 1990
- Product Code
- DRS
- 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | FDA class 2 | Cardiovascular |
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Other Clearances by THOMAS J. FOGARTY, M.D.
| K Number | Device Name | ||
|---|---|---|---|
| K884154 | TRANSLUMINAL ENDARTERECTOMY DEVICE | Dec 27, 1988 | Substantially Equivalent |
| K831809 | FOGARTY OCCLUDER PAD | Aug 27, 1984 | Substantially Equivalent |
| K841310 | GASTROINTESTINAL DILATOR | Jul 31, 1984 | Substantially Equivalent |
| K834451 | COAXIAL BALLOON GASTROESOPHAGEAL DILA | Feb 4, 1984 | Substantially Equivalent |
| K831384 | COAXIAL BALLOON URETHRAL DILATOR | Jul 26, 1983 | Substantially Equivalent |