FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOTRACHEAL TUBE CHANGERS
K Number: K102127
·
Decision Aug 27, 2010
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
45
Review Days
29
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Basic Information
- Device Name
- ENDOTRACHEAL TUBE CHANGERS
- K Number
- K102127
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Industries, Inc.
- Date Received
- July 29, 2010
- Decision Date
- August 27, 2010
- Product Code
- LNZ
- 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 |
|---|---|---|---|
| LNZ | Changer, Tube, Endotracheal | FDA class 2 | Anesthesiology |
Other Clearances by Instrumentation Industries, Inc.
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| K991355 | METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE | Jan 27, 2000 | Substantially Equivalent |
| K992670 | OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 | Sep 17, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K991785 | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR | Aug 17, 1999 | Substantially Equivalent |