FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPR FILTERSHIELD
K Number: K980066
·
Decision Jul 16, 1998
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
16
Review Days
190
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Basic Information
- Device Name
- CPR FILTERSHIELD
- K Number
- K980066
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Plasco, Inc.
- Date Received
- January 7, 1998
- Decision Date
- July 16, 1998
- Product Code
- BTM
- 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
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FDA 510(k)
FDA Class 2
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Other Clearances by Plasco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953414 | CPR MICROMASK WITH OXYGEN INLET | Mar 20, 1996 | Substantially Equivalent |
| K951483 | CPR MICROMASK | Oct 19, 1995 | Substantially Equivalent |
| 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 |
| K880337 | MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 | Apr 14, 1988 | Substantially Equivalent |
| K870623 | ENTERAL ADMINISTRATION SET | Jun 26, 1987 | Substantially Equivalent |
| K870019 | THE LAHR BALLOON | Apr 1, 1987 | Substantially Equivalent |
| K870796 | MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY | Apr 1, 1987 | Substantially Equivalent |