FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
I.V. START KIT (AHC-50-54954
K Number: K924192
·
Decision Aug 27, 1993
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
14
Review Days
372
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Basic Information
- Device Name
- I.V. START KIT (AHC-50-54954
- K Number
- K924192
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- American Healthcare Corp.
- Date Received
- August 20, 1992
- Decision Date
- August 27, 1993
- Product Code
- KGX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
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CARE BAND ANTIBACTERIAL BANDAGES
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SYVEK PATCH
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ADHESIVE BANDAGES WITH OTC DRUG
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TARGETT PATCH
FDA 510(k)
FDA Class 1
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PARALLEL
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by American Healthcare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K923938 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER | Jun 17, 1993 | Unknown |
| K923939 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER | Jun 17, 1993 | Unknown |
| K923940 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE | Jun 17, 1993 | Unknown |
| K923941 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE | Jun 17, 1993 | Unknown |
| K924193 | TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) | Jun 16, 1993 | Unknown |
| K924191 | TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL | Apr 2, 1993 | Unknown |
| K924195 | TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES | Jan 6, 1993 | Substantially Equivalent |
| K924194 | TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686) | Jan 6, 1993 | Unknown |
| K923834 | TRACHEOSTOMY CARE SET WITH GLOVES | Dec 10, 1992 | Unknown |
| K905136 | GAUZE SPONGES, INTERNAL AND EXTERNAL | Mar 6, 1991 | Substantially Equivalent |