FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONTINUOUS VENTILATOR
K Number: K844809
·
Decision Jun 27, 1985
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
76
Applicant Total
15
Review Days
182
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Basic Information
- Device Name
- CONTINUOUS VENTILATOR
- K Number
- K844809
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Hamilton Medical, Inc.
- Date Received
- December 27, 1984
- Decision Date
- June 27, 1985
- Product Code
- GBX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GBX | Catheter, Irrigation | FDA class 1 | General, Plastic Surgery |
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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 |
| K894426 | LEONARDO INFORMATION SYSTEM | Sep 26, 1989 | Substantially Equivalent |
| K894316 | AMADEUS VENTILATOR | Sep 22, 1989 | Substantially Equivalent |