FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOME, DISPOSABLE, STERILE
K Number: K851989
·
Decision Aug 19, 1985
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
7
Review Days
104
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Basic Information
- Device Name
- DOME, DISPOSABLE, STERILE
- K Number
- K851989
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Transamerica Delaval, Inc.
- Date Received
- May 7, 1985
- Decision Date
- August 19, 1985
- 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 Transamerica Delaval, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853996 | DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE | May 7, 1986 | Substantially Equivalent |
| K851988 | ADMINISTRATION SET | Aug 16, 1985 | Substantially Equivalent |
| K851987 | FLUSH DEVICE, AUTOMATIC | Aug 16, 1985 | Substantially Equivalent |
| K851986 | STOPCOCKS | May 23, 1985 | Substantially Equivalent |
| K833171 | MONITORING KIT | Sep 6, 1984 | Substantially Equivalent |
| K833170 | FLUSH DEVICE | Aug 12, 1984 | Substantially Equivalent |