FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
MID-500
K Number: K940117
·
Decision Jun 10, 1994
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
87
Applicant Total
12
Review Days
151
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MID-500
- K Number
- K940117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Block Medical, Inc.
- Date Received
- January 10, 1994
- Decision Date
- June 10, 1994
- Product Code
- MEB
- 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 |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MEB), ordered by most recent decision date.
SMARTeZ Elastomeric Infusion Pump (RS series)
FDA 510(k)
FDA Class 2
·General Hospital
InfuLife
FDA 510(k)
FDA Class 2
·General Hospital
SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
FDA 510(k)
FDA Class 2
·General Hospital
ON-Q* Pump with Bolus
FDA 510(k)
FDA Class 2
·General Hospital
SMARTez elastomeric infusion pump
FDA 510(k)
FDA Class 2
·General Hospital
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
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 |
| 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 |