FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEARVIEW ENDOSCOPE COVER
K Number: K080740
·
Decision Dec 31, 2008
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
16
Review Days
289
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Basic Information
- Device Name
- CLEARVIEW ENDOSCOPE COVER
- K Number
- K080740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Invotec International, Inc.
- Date Received
- March 17, 2008
- Decision Date
- December 31, 2008
- Product Code
- EOB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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| K971000 | EPISTAXIS NASAL PACK | May 14, 1997 | Substantially Equivalent |
| K930114 | TRACHEOSTOMY T-TUBE | Mar 19, 1993 | Substantially Equivalent |
| K911041 | INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE | Jun 4, 1991 | Substantially Equivalent |
| K911040 | INVOTEC MICROSCOPE DRAPE | Jun 3, 1991 | Substantially Equivalent |
| K911039 | INVOTEC EAR DRAPE | May 13, 1991 | Substantially Equivalent |
| K901923 | INVOTEC POLY-MESH MANDIBULAR TRAY | Oct 31, 1990 | Substantially Equivalent |