FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY
K Number: K850263
·
Decision Mar 25, 1985
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
50
Applicant Total
6
Review Days
61
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Basic Information
- Device Name
- PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY
- K Number
- K850263
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Plasmedics, Inc.
- Date Received
- January 23, 1985
- Decision Date
- March 25, 1985
- Product Code
- BSJ
- 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 |
|---|---|---|---|
| BSJ | Mask, Gas, Anesthetic | FDA class 1 | Anesthesiology |
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Other Clearances by Plasmedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853559 | STERILE BIOPSY NEEDLES | Sep 11, 1985 | Substantially Equivalent |
| K831601 | APNEA ALARM FOR ADULT-PEDIATRIC & NEON | Sep 26, 1983 | Substantially Equivalent |
| K831650 | ANESTHESIA/RESPIRATORY DISCONNECT - | Sep 12, 1983 | Substantially Equivalent |
| K830604 | WEDGE PRESSURE CATHETER | Jul 18, 1983 | Substantially Equivalent |
| K823351 | CENTRAL VENOUS CATHETER | Dec 9, 1982 | Substantially Equivalent |