FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNIMED SUPERIOR TRANSDUCER PROTECTOR
K Number: K851734
·
Decision May 23, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
34
Applicant Total
12
Review Days
28
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Basic Information
- Device Name
- OMNIMED SUPERIOR TRANSDUCER PROTECTOR
- K Number
- K851734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Omni Intl., Inc.
- Date Received
- April 25, 1985
- Decision Date
- May 23, 1985
- Product Code
- FIB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIB | Protector, Transducer, Dialysis | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Omni Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K984066 | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM | Jan 13, 1999 | Substantially Equivalent |
| K984064 | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE | Jan 8, 1999 | Substantially Equivalent |
| K853255 | OMNIMED I.V. SOLUTION ADMIN. SET | Aug 23, 1985 | Substantially Equivalent |
| K851938 | OMNIMED SURGICAL GOWN | Jun 28, 1985 | Substantially Equivalent |
| K851654 | OMNIMED CLAMP | May 31, 1985 | Substantially Equivalent |
| K850706 | F-SERIES IMPLANT | Apr 10, 1985 | Substantially Equivalent |
| K850112 | OMNIMED IV SOLUTION ADMINISTRATION SET | Feb 22, 1985 | Substantially Equivalent |
| K850066 | OMNIMED NASAL OXYGEN CANNULA | Jan 24, 1985 | Substantially Equivalent |
| K831147 | OMNIPROBE ELECTRICAL NERVE STIMULATOR | Jul 18, 1983 | Substantially Equivalent |
| K821523 | OMNI TENS | Jun 16, 1982 | Substantially Equivalent |