FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OMNIMED NASAL OXYGEN CANNULA
K Number: K850066
·
Decision Jan 24, 1985
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
41
Applicant Total
12
Review Days
16
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Basic Information
- Device Name
- OMNIMED NASAL OXYGEN CANNULA
- K Number
- K850066
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Omni Intl., Inc.
- Date Received
- January 8, 1985
- Decision Date
- January 24, 1985
- Product Code
- CAT
- 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 |
|---|---|---|---|
| CAT | Cannula, Nasal, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAT), ordered by most recent decision date.
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
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NASAL CANNULA
FDA 510(k)
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4 SURE TM NASAL OXYGEN CANNULA
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SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
FDA 510(k)
FDA Class 1
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CANNULA NASAL OXYGEN
FDA 510(k)
FDA Class 1
·Anesthesiology
NASAL OXYGEN CANNULA, 81585, 81587 & 81589
FDA 510(k)
FDA Class 1
·Anesthesiology
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 |
| K851734 | OMNIMED SUPERIOR TRANSDUCER PROTECTOR | May 23, 1985 | Substantially Equivalent |
| K850706 | F-SERIES IMPLANT | Apr 10, 1985 | Substantially Equivalent |
| K850112 | OMNIMED IV SOLUTION ADMINISTRATION SET | Feb 22, 1985 | Substantially Equivalent |
| K831147 | OMNIPROBE ELECTRICAL NERVE STIMULATOR | Jul 18, 1983 | Substantially Equivalent |
| K821523 | OMNI TENS | Jun 16, 1982 | Substantially Equivalent |