FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXHALATION VALVE
K Number: K984481
·
Decision Jan 29, 1999
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
18
Review Days
44
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Basic Information
- Device Name
- EXHALATION VALVE
- K Number
- K984481
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intersurgical, Inc.
- Date Received
- December 16, 1998
- Decision Date
- January 29, 1999
- Product Code
- CBP
- 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 |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | FDA class 2 | Anesthesiology |
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Other Clearances by Intersurgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122077 | MANOMETER | Jan 10, 2013 | Substantially Equivalent |
| K122075 | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER | Dec 20, 2012 | Substantially Equivalent |
| K121026 | FLO-GUARD BREATHING FILTER | Nov 2, 2012 | Substantially Equivalent |
| K092451 | INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER | Oct 29, 2010 | Substantially Equivalent |
| K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 | May 18, 2010 | Substantially Equivalent |
| K092409 | HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER | Mar 10, 2010 | Substantially Equivalent |
| K032322 | CLEAR-THERM MICRO HME, MODEL 1441 | May 13, 2004 | Substantially Equivalent |
| K024270 | CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 | Jun 24, 2003 | Substantially Equivalent |
| K990949 | CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT | Jun 15, 1999 | Substantially Equivalent |
| K983610 | CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18 | Apr 30, 1999 | Substantially Equivalent |