FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTERTECH METERED DOSE ELBOW
K Number: K895144
·
Decision Oct 19, 1989
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
10
Review Days
62
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Basic Information
- Device Name
- INTERTECH METERED DOSE ELBOW
- K Number
- K895144
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Intertech/Ohio
- Date Received
- August 18, 1989
- Decision Date
- October 19, 1989
- Product Code
- BZA
- 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | FDA class 1 | Anesthesiology |
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Other Clearances by Intertech/Ohio
| K Number | Device Name | ||
|---|---|---|---|
| K890346 | INTERTECH UNIVERSAL HYDROPHOBIC FILTER | Mar 1, 1989 | Substantially Equivalent |
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| K884526 | ADULT RESUSCITATOR WITH MASK AND FILTER | Nov 16, 1988 | Substantially Equivalent |
| K882204 | RESUSCITATOR VALVE ASSEMBLY W/FILTER | Jul 8, 1988 | Substantially Equivalent |
| K880394 | FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR | Feb 29, 1988 | Substantially Equivalent |
| K863033 | PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS | Aug 20, 1986 | Substantially Equivalent |
| K862020 | HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER | Jun 30, 1986 | Substantially Equivalent |
| K860650 | 90 DEGREE ELBOW & STRAIGHT CONNECTOR | Mar 28, 1986 | Substantially Equivalent |
| K861056 | STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG | Mar 27, 1986 | Substantially Equivalent |