FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPR MICROMASK WITH OXYGEN INLET
K Number: K953414
·
Decision Mar 20, 1996
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
16
Review Days
244
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Basic Information
- Device Name
- CPR MICROMASK WITH OXYGEN INLET
- K Number
- K953414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Plasco, Inc.
- Date Received
- July 20, 1995
- Decision Date
- March 20, 1996
- Product Code
- CBP
- 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 |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | FDA class 2 | Anesthesiology |
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Other Clearances by Plasco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980066 | CPR FILTERSHIELD | Jul 16, 1998 | Substantially Equivalent |
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| K950769 | CPR MICROMASK PLUS CATALOG NO 73-402 | Mar 10, 1995 | Substantially Equivalent |
| K950770 | CPR MICROSHIELD II | Mar 10, 1995 | Substantially Equivalent |
| K943386 | CPR MICROMASK | Feb 21, 1995 | Substantially Equivalent |
| K932649 | PHARMAFEED | Nov 16, 1993 | Substantially Equivalent |
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| K870019 | THE LAHR BALLOON | Apr 1, 1987 | Substantially Equivalent |
| K870796 | MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY | Apr 1, 1987 | Substantially Equivalent |