FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENSORMEDICS MICROGARD MICROBIAL FILTER
K Number: K934272
·
Decision Nov 24, 1993
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
26
Review Days
85
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SENSORMEDICS MICROGARD MICROBIAL FILTER
- K Number
- K934272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sensor Medics Corp.
- Date Received
- August 31, 1993
- Decision Date
- November 24, 1993
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAH), ordered by most recent decision date.
Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
FDA 510(k)
FDA Class 2
·Anesthesiology
Ambu® Virobac II® Exhalation Filter
FDA 510(k)
FDA Class 2
·Anesthesiology
Besmed Bacterial Filter and HMEF
FDA 510(k)
FDA Class 2
·Anesthesiology
Breathing circuit bacterial/viral filter
FDA 510(k)
FDA Class 2
·Anesthesiology
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
FDA 510(k)
FDA Class 2
·Anesthesiology
TNI Clear-Guard 3 angled breathing filter (1545020)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Sensor Medics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K032516 | HIOX80 AEROSOL ADAPTER | Mar 4, 2004 | Substantially Equivalent |
| K031745 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION | Feb 13, 2004 | Substantially Equivalent |
| K031883 | LYRA NASAL MASK | Aug 25, 2003 | Substantially Equivalent |
| K030943 | MODIFICATION TO HIOX | Apr 22, 2003 | Substantially Equivalent |
| K022192 | PEGASUS NASAL CPAP SYSTEM | Jan 24, 2003 | Substantially Equivalent |
| K020665 | HI-OX | Jul 30, 2002 | Substantially Equivalent |
| K012085 | SOMNO STAR & SERIES SLEEP SYSTEM | Aug 2, 2001 | Substantially Equivalent |
| K012034 | MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT | Jul 24, 2001 | Substantially Equivalent |
| K991972 | INFANT FLOW SYSTEM | Aug 13, 1999 | Substantially Equivalent |
| K984254 | INFANT FLOW NCPAP MASKS | Feb 24, 1999 | Substantially Equivalent |