FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLEX BLUE
K Number: K950318
·
Decision Feb 13, 1995
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
46
Applicant Total
18
Review Days
18
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Basic Information
- Device Name
- FLEX BLUE
- K Number
- K950318
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5770
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- King Systems Corp.
- Date Received
- January 26, 1995
- Decision Date
- February 13, 1995
- Product Code
- CBH
- 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 |
|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | FDA class 1 | 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 |
| K973797 | BREATHING CIRCUIT BACTERIAL FILTER | Mar 12, 1998 | Substantially Equivalent |
| K953513 | XENON CIRCUIT | Nov 3, 1995 | Substantially Equivalent |
| K951093 | KAB SYSTEM | Mar 24, 1995 | Substantially Equivalent |