FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BREATHING CIRCUIT BACTERIAL FILTER
K Number: K973797
·
Decision Mar 12, 1998
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
18
Review Days
157
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Basic Information
- Device Name
- BREATHING CIRCUIT BACTERIAL FILTER
- K Number
- K973797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- King Systems Corp.
- Date Received
- October 6, 1997
- Decision Date
- March 12, 1998
- 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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Other Clearances by King Systems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K033189 | KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 | May 4, 2004 | Substantially Equivalent |
| K033186 | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 | Apr 14, 2004 | Substantially Equivalent |
| K021634 | KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 | Jan 9, 2003 | Substantially Equivalent |
| K012485 | MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE | Oct 9, 2001 | Substantially Equivalent |
| K010040 | SLEEVED FILTER | Mar 9, 2001 | Substantially Equivalent |
| K990614 | HME-BOOSTER | May 23, 2000 | Substantially Equivalent |
| K983817 | BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) | Mar 1, 1999 | Substantially Equivalent |
| K953513 | XENON CIRCUIT | Nov 3, 1995 | Substantially Equivalent |
| K951093 | KAB SYSTEM | Mar 24, 1995 | Substantially Equivalent |
| K950318 | FLEX BLUE | Feb 13, 1995 | Substantially Equivalent |