FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
K Number: K965016
·
Decision Dec 2, 1997
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
15
Review Days
351
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Basic Information
- Device Name
- ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
- K Number
- K965016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gibeck, Inc.
- Date Received
- December 16, 1996
- Decision Date
- December 2, 1997
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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Other Clearances by Gibeck, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K953491 | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | 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 |