FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MERCURY MEDICAL CPR BAG EXHALATION FILTER
K Number: K954490
·
Decision Oct 3, 1996
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
15
Review Days
372
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Basic Information
- Device Name
- MERCURY MEDICAL CPR BAG EXHALATION FILTER
- K Number
- K954490
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mercury Medical
- Date Received
- September 27, 1995
- Decision Date
- October 3, 1996
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K142096 | T-PIECE RESUSCITATOR | Oct 17, 2014 | Substantially Equivalent |
| K090710 | MERCURY CPAP | Aug 20, 2009 | Substantially Equivalent |
| K083056 | NEO-STAT CO2 <KG | Feb 23, 2009 | Substantially Equivalent |
| K032593 | MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER | Feb 3, 2004 | Substantially Equivalent |
| K031814 | STATCO2METER, MODEL 10-55372 | Aug 14, 2003 | Substantially Equivalent |
| K031411 | MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 | Jul 30, 2003 | Substantially Equivalent |
| K021576 | MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 | Nov 4, 2002 | Substantially Equivalent |
| K001714 | MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 | Nov 3, 2000 | Substantially Equivalent |
| K000073 | MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA | Mar 1, 2000 | Substantially Equivalent |
| K970756 | MERCURY MEDICAL REUSABLE CPR BAG | Oct 31, 1997 | Substantially Equivalent |