FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALADDIN MONITORING OXYGEN/AIR MIXER
K Number: K960359
·
Decision Apr 24, 1996
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
54
Applicant Total
15
Review Days
90
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Basic Information
- Device Name
- ALADDIN MONITORING OXYGEN/AIR MIXER
- K Number
- K960359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5330
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hamilton Medical, Inc.
- Date Received
- January 25, 1996
- Decision Date
- April 24, 1996
- Product Code
- BZR
- 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 |
|---|---|---|---|
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 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 |
| 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 |
| K894426 | LEONARDO INFORMATION SYSTEM | Sep 26, 1989 | Substantially Equivalent |
| K894316 | AMADEUS VENTILATOR | Sep 22, 1989 | Substantially Equivalent |
| K881482 | VEOLAR VENTILATOR | Jun 16, 1988 | Substantially Equivalent |