FDA 510(k)
FDA class 1
Substantially Equivalent
🇸🇪 Sweden
BREATH-EASY, MODIFICATION
K Number: K914416
·
Decision Jun 23, 1992
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
15
Applicant Total
16
Review Days
272
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Basic Information
- Device Name
- BREATH-EASY, MODIFICATION
- K Number
- K914416
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1140
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Icor AB
- Date Received
- September 25, 1991
- Decision Date
- June 23, 1992
- Product Code
- HME
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HME | Chair, Ophthalmic, Ac-Powered | FDA class 1 | Ophthalmic |
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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 |
| K952823 | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE | Jul 13, 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 |
| 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 |