FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001
K Number: K070201
·
Decision Aug 1, 2007
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
1
Applicant Total
645
Review Days
191
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Basic Information
- Device Name
- BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001
- K Number
- K070201
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. Bard, Inc.
- Date Received
- January 22, 2007
- Decision Date
- August 1, 2007
- Product Code
- PHU
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| PHU | Intra-Abdominal Pressure Monitoring Device | FDA unclassified | Unknown |
Similar 510(k) Clearances
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