FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOMEPUMP NSF
K Number: K932740
·
Decision Oct 6, 1993
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
63
Applicant Total
12
Review Days
120
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Basic Information
- Device Name
- HOMEPUMP NSF
- K Number
- K932740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6885
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Block Medical, Inc.
- Date Received
- June 8, 1993
- Decision Date
- October 6, 1993
- Product Code
- MED
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| MED | Sterilant, Medical Devices | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MED), ordered by most recent decision date.
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Block Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944692 | C-SERIES HOMEPUMP | May 2, 1995 | Substantially Equivalent |
| K940117 | MID-500 | Jun 10, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K934551 | VERIFUSE AMBULATORY PUMP | Mar 17, 1994 | Substantially Equivalent |
| K935236 | FLOW CONTROLLING EXTENSION SET | Feb 24, 1994 | Substantially Equivalent |
| K904663 | AUTO SASH (TM) | Nov 23, 1992 | Substantially Equivalent |
| K914924 | CHEMO PRIMING PIN(TM) | Mar 6, 1992 | Substantially Equivalent |
| K914854 | THUMPER | Jan 24, 1992 | Substantially Equivalent |
| K914855 | MULTIPLE DOSE CONTROLLER | Jan 24, 1992 | Substantially Equivalent |
| K910695 | AUTO SASH (TM) | Mar 21, 1991 | Substantially Equivalent |
| K902891 | VERIFUSE AMBULATORY PUMP | Nov 21, 1990 | Substantially Equivalent |