FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEONARDO INFORMATION SYSTEM
K Number: K894426
·
Decision Sep 26, 1989
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
15
Review Days
71
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Basic Information
- Device Name
- LEONARDO INFORMATION SYSTEM
- K Number
- K894426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Hamilton Medical, Inc.
- Date Received
- July 17, 1989
- Decision Date
- September 26, 1989
- Product Code
- CBK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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Other Clearances by Hamilton Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040574 | GALILEO GOLD | Oct 27, 2004 | Substantially Equivalent |
| K001686 | GALILEO VENTILATOR | Jun 23, 2000 | Substantially Equivalent - Subject to Tracking Reg. |
| K982910 | HAMILTON MEDICAL GALILEOVENTILATOR | Sep 14, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K990293 | ALADDIN II MONITORING OXYGEN/AIR MONITOR | Mar 16, 1999 | Substantially Equivalent |
| K960359 | ALADDIN MONITORING OXYGEN/AIR MIXER | Apr 24, 1996 | Substantially Equivalent |
| K945740 | INFANT FLOW SYSTEM | Mar 23, 1995 | Substantially Equivalent |
| K901448 | VEOLAR VENTILATOR | Dec 20, 1991 | Substantially Equivalent |
| K900465 | MAX TRANSPORT VENTILATOR | Jun 18, 1990 | Substantially Equivalent |
| K894316 | AMADEUS VENTILATOR | Sep 22, 1989 | Substantially Equivalent |
| K881482 | VEOLAR VENTILATOR | Jun 16, 1988 | Substantially Equivalent |