FDA 510(k)
FDA class 1
Substantially Equivalent
🇸🇪 Sweden
FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE
K Number: K952823
·
Decision Jul 13, 1995
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
72
Applicant Total
16
Review Days
23
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Basic Information
- Device Name
- FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE
- K Number
- K952823
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Icor AB
- Date Received
- June 20, 1995
- Decision Date
- July 13, 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
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Other Clearances by Icor AB
| K Number | Device Name | ||
|---|---|---|---|
| K954402 | ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | May 22, 1996 | Substantially Equivalent |
| K953507 | TYPE 1 & 2 (HUMIDAIR I & II) | Sep 7, 1995 | Substantially Equivalent |
| K952325 | ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | Jul 31, 1995 | Substantially Equivalent |
| K941987 | HEAT AND MOISTURE EXCHANGERS AND FILTERS | Aug 15, 1994 | Substantially Equivalent |
| K940041 | COLIBRI | Jul 27, 1994 | Substantially Equivalent |
| K941436 | AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF | Jun 8, 1994 | Substantially Equivalent |
| K925622 | FHB, FHB-T, FHBFLEX, FHBFLEX-T | May 26, 1993 | Substantially Equivalent |
| K914416 | BREATH-EASY, MODIFICATION | Jun 23, 1992 | Substantially Equivalent |
| K904338 | ICOR HCH 4, ICOR HCH 7 | Dec 4, 1990 | Substantially Equivalent |
| K900150 | HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE | Jan 25, 1990 | Substantially Equivalent |