FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSFER-AID(TM)
K Number: K913985
·
Decision Mar 18, 1992
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
9
Review Days
195
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Basic Information
- Device Name
- TRANSFER-AID(TM)
- K Number
- K913985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Healthtek, Inc.
- Date Received
- September 5, 1991
- Decision Date
- March 18, 1992
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by Healthtek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923448 | EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG | Jul 28, 1993 | Substantially Equivalent |
| K913608 | SNAPPER | Nov 29, 1991 | Substantially Equivalent |
| K881590 | ADFUSE(TM) | May 23, 1988 | Substantially Equivalent |
| K874495 | ADCOMP 4000 HP SYSTEM | Feb 16, 1988 | Substantially Equivalent |
| K873848 | RETROBULBAR NEEDLE | Oct 23, 1987 | Substantially Equivalent |
| K860610 | ADCOMP | Jul 8, 1986 | Substantially Equivalent |
| K860372 | FAST FLOW XX (AQUEOUS SOLUTION FILTER) | May 30, 1986 | Substantially Equivalent |
| K854008 | STATLOCK | Nov 13, 1985 | Substantially Equivalent |