FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WARM N WET HME W/LUER ADAPTER
K Number: K953619
·
Decision Aug 25, 1995
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
72
Applicant Total
27
Review Days
22
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Basic Information
- Device Name
- WARM N WET HME W/LUER ADAPTER
- K Number
- K953619
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hospitak, Inc.
- Date Received
- August 3, 1995
- Decision Date
- August 25, 1995
- Product Code
- BYD
- 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 |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYD), ordered by most recent decision date.
HEAT & MOISTURE EXCHANGER
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DISPOSABLE HME/FILTER
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HEAT MOISTURE EXCHANGER
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TYPE 1 & 2 (HUMIDAIR I & II)
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HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
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HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Hospitak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955483 | TRACH MASK MODEL (245, 246) | Feb 28, 1996 | Substantially Equivalent |
| K954787 | ILLUMINATOR | Jan 31, 1996 | Substantially Equivalent |
| K953620 | WARM N WET HMEF W/LUER ADAPTER | Aug 25, 1995 | Substantially Equivalent |
| K915750 | DISPOSABLE BACTERIAL BREATHNG FILTER | Nov 30, 1994 | Substantially Equivalent |
| K920842 | AEROSOL DELIVERY SYSTEMS | May 15, 1992 | Substantially Equivalent |
| K915228 | DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL | Feb 11, 1992 | Substantially Equivalent |
| K873286 | DISPOSABLE, MANUAL PULMONARY RESUSCITATOR | Oct 26, 1987 | Substantially Equivalent |
| K853600 | INFLATABLE AIR SPLINTS | Sep 19, 1985 | Substantially Equivalent |
| K844328 | OXYGEN CONCENTRATOR | Dec 4, 1984 | Substantially Equivalent |
| K843212 | LOW PRESSURE ALARM FOR OXYGEN CYLINDER | Sep 19, 1984 | Substantially Equivalent |