FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-SERIES HOMEPUMP
K Number: K944692
·
Decision May 2, 1995
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
12
Review Days
221
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Basic Information
- Device Name
- C-SERIES HOMEPUMP
- K Number
- K944692
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Block Medical, Inc.
- Date Received
- September 23, 1994
- Decision Date
- May 2, 1995
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Block Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K932740 | HOMEPUMP NSF | Oct 6, 1993 | 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 |