FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFANT FLOW SYSTEM
K Number: K945740
·
Decision Mar 23, 1995
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
15
Review Days
120
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Basic Information
- Device Name
- INFANT FLOW SYSTEM
- K Number
- K945740
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hamilton Medical, Inc.
- Date Received
- November 23, 1994
- Decision Date
- March 23, 1995
- Product Code
- BZO
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZO), ordered by most recent decision date.
UNICOR, INC. CORRUGATED TUBING
FDA 510(k)
FDA Class 1
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UNICOR, INC. VENTILATOR HOSES
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FDA Class 1
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PRIMA VENTILATOR HOSES
FDA 510(k)
FDA Class 1
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PRIMA CUSTOM ANESTESIA CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VOLUMN VENTILATORSS
FDA 510(k)
FDA Class 1
·Anesthesiology
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 |
| 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 |