FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇾 Malaysia
WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
K Number: K954754
·
Decision Dec 8, 1995
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
9
Review Days
53
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Basic Information
- Device Name
- WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
- K Number
- K954754
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Unomedical Sdn Bhd
- Date Received
- October 16, 1995
- Decision Date
- December 8, 1995
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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Other Clearances by Unomedical Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K973076 | EUROMEDICAL HAEMATURIA FOLEY CATHETER | Sep 16, 1998 | Substantially Equivalent |
| K962389 | EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE | Nov 21, 1996 | Substantially Equivalent |
| K954751 | SILICONE ENDOTRACHEAL TUBE | Dec 8, 1995 | Substantially Equivalent |
| K954753 | PEDIATRIC SILICONE ENDOTRACHEAL TUBE | Dec 8, 1995 | Substantially Equivalent |
| K954750 | PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE | Dec 8, 1995 | Substantially Equivalent |
| K951696 | ENDOTRACHEAL TUBE | May 22, 1995 | Substantially Equivalent |
| K951697 | PEDIATRIC ENDOTRACHEAL TUBE | May 22, 1995 | Substantially Equivalent |
| K945806 | SILICATH ALL SILICONE FOLEY CATHETER | Mar 21, 1995 | Substantially Equivalent |