FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN MASKS
K Number: K823141
·
Decision Nov 29, 1982
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
7
Review Days
35
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Basic Information
- Device Name
- OXYGEN MASKS
- K Number
- K823141
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Seven Harvest Intl. Import & Export
- Date Received
- October 25, 1982
- Decision Date
- November 29, 1982
- Product Code
- BYG
- 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYG), ordered by most recent decision date.
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VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
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WESTMED PEDIATRIC AND ADULT AEROSOL MASK
FDA 510(k)
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·Anesthesiology
Other Clearances by Seven Harvest Intl. Import & Export
| K Number | Device Name | ||
|---|---|---|---|
| K940793 | DOUBLE TRACH SWIVEL CONNECTOR | Jul 1, 1994 | Substantially Equivalent |
| K823506 | NASAL CANNULA | Dec 9, 1982 | Substantially Equivalent |
| K823142 | OXYGEN TUBINGS | Nov 29, 1982 | Substantially Equivalent |
| K823143 | BUBBLE HUMIDIFIERS | Nov 29, 1982 | Substantially Equivalent |
| K820709 | AIRWAYS | Jun 25, 1982 | Substantially Equivalent |
| K813074 | CONNECTORS & ADAPTERS | Dec 31, 1981 | Substantially Equivalent |