FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOBLES-LAI ENGINEERING INFUSION PUMP
K Number: K895688
·
Decision Feb 26, 1990
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
8
Applicant Total
5
Review Days
157
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Basic Information
- Device Name
- NOBLES-LAI ENGINEERING INFUSION PUMP
- K Number
- K895688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Nobles-Lai Engineering, Inc.
- Date Received
- September 22, 1989
- Decision Date
- February 26, 1990
- Product Code
- DQI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| DQI | Withdrawal/Infusion Pump | FDA class 2 | Cardiovascular |
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Other Clearances by Nobles-Lai Engineering, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953554 | NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES | Oct 18, 1995 | Substantially Equivalent |
| K933345 | NOBLES-LAI ENDOSCOPIC/LAPAROSCOPIC | Feb 22, 1994 | Substantially Equivalent |
| K920026 | NOBLES-LAI IMAGING SYSTEM | Jul 28, 1992 | Unknown |
| K914457 | DISPOSABLE OPTICAL VALVULOTOME | Feb 5, 1992 | Substantially Equivalent |