FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE
K Number: K911041
·
Decision Jun 4, 1991
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
50
Applicant Total
16
Review Days
88
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Basic Information
- Device Name
- INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE
- K Number
- K911041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1850
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Invotec International, Inc.
- Date Received
- March 8, 1991
- Decision Date
- June 4, 1991
- Product Code
- IXA
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IXA | Cassette, Radiographic Film | FDA class 2 | Radiology |
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|---|---|---|---|
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| K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | Mar 3, 2003 | Substantially Equivalent |
| K973580 | INVOTEC CLEAN PAD | Dec 10, 1997 | Substantially Equivalent |
| K973578 | INVOTEC EAR TAMPON (WICK) W/STRING | Nov 6, 1997 | Substantially Equivalent |
| K971000 | EPISTAXIS NASAL PACK | May 14, 1997 | Substantially Equivalent |
| K930114 | TRACHEOSTOMY T-TUBE | Mar 19, 1993 | 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 |