FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MECONIUM ASPIRATION
K Number: K912596
·
Decision Jul 30, 1991
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
5
Review Days
50
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Basic Information
- Device Name
- MECONIUM ASPIRATION
- K Number
- K912596
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pacific Device, Inc.
- Date Received
- June 10, 1991
- Decision Date
- July 30, 1991
- Product Code
- BSY
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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Other Clearances by Pacific Device, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972464 | VITALMIX PLUS EMPTY I.V. CONTAINER | Nov 5, 1997 | Substantially Equivalent |
| K923782 | TRANSFER SET | Jul 2, 1993 | Substantially Equivalent |
| K912860 | INTRAVASCULAR ADMINISTRATION SETS | Aug 28, 1991 | Substantially Equivalent |
| K902482 | VITALMIX (SET & BAG) | Jul 2, 1990 | Substantially Equivalent |