FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇭 Switzerland
DOUBLE LUMEN E T ADAPTOR
K Number: K862435
·
Decision Oct 22, 1986
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
12
Review Days
118
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Basic Information
- Device Name
- DOUBLE LUMEN E T ADAPTOR
- K Number
- K862435
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Acutronic Medical Systems AG
- Date Received
- June 26, 1986
- Decision Date
- October 22, 1986
- Product Code
- BZA
- 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | FDA class 1 | Anesthesiology |
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Other Clearances by Acutronic Medical Systems AG
| K Number | Device Name | ||
|---|---|---|---|
| K012691 | MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES | Dec 20, 2002 | Substantially Equivalent |
| K012693 | MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES | Aug 1, 2002 | Substantially Equivalent |
| K936009 | AMS 3000M | May 3, 1995 | Substantially Equivalent |
| K900745 | VS-200S JET VENTILATOR | Apr 29, 1991 | Substantially Equivalent |
| K900744 | AMS 3000 PORTABLE JET VENTILATOR | Apr 29, 1991 | Substantially Equivalent |
| K883865 | EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010 | Jun 8, 1989 | Substantially Equivalent |
| K863155 | UNIVERSAL JET VENTILATOR MODEL AMS-1000 | Sep 28, 1987 | Substantially Equivalent |
| K863154 | HEATED JET HUMIDIFIER MODEL AMS-1020 | Jan 12, 1987 | Substantially Equivalent |
| K862436 | TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) | Nov 3, 1986 | Substantially Equivalent |
| K862433 | UNI-JET CONNECTOR | Aug 6, 1986 | Substantially Equivalent |