FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HP M2376A DEVICE LINK SYSTEM
K Number: K984194
·
Decision Apr 30, 1999
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
17
Applicant Total
230
Review Days
158
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Basic Information
- Device Name
- HP M2376A DEVICE LINK SYSTEM
- K Number
- K984194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hewlett-Packard Co.
- Date Received
- November 23, 1998
- Decision Date
- April 30, 1999
- Product Code
- MQS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| MQS | System, Hemodialysis, Access Recirculation Monitoring | FDA class 2 | Gastroenterology, Urology |
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