FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
K Number: K953491
·
Decision Aug 25, 1995
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
72
Applicant Total
15
Review Days
31
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Basic Information
- Device Name
- HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
- K Number
- K953491
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gibeck, Inc.
- Date Received
- July 25, 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
FDA 510(k)
FDA Class 1
·Anesthesiology
WARM N WET HMEF W/LUER ADAPTER
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Gibeck, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K965016 | ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) | Dec 2, 1997 | Substantially Equivalent |
| K964377 | THERMAL REGULATION SYSTEM BLANKET | Apr 23, 1997 | Substantially Equivalent |
| K964382 | HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) | Apr 15, 1997 | Substantially Equivalent |
| K960511 | GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET | Jan 13, 1997 | Substantially Equivalent |
| K954828 | ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT | May 2, 1996 | Substantially Equivalent |
| K953544 | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | Aug 25, 1995 | Substantially Equivalent |
| K952845 | HUMID-VENT TRACH-VENT | Jul 25, 1995 | Substantially Equivalent |
| K952844 | HUMID-VENT 2 | Jul 20, 1995 | Substantially Equivalent |
| K952750 | HUMID-VENT 1 | Jul 20, 1995 | Substantially Equivalent |
| K952084 | HUMID-VENT FILTER PEDI | Jun 12, 1995 | Substantially Equivalent |