FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PALCO LABS LOADMATIC
K Number: K913694
·
Decision Dec 17, 1991
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
9
Review Days
120
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Basic Information
- Device Name
- PALCO LABS LOADMATIC
- K Number
- K913694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Palco Laboratories, Inc.
- Date Received
- August 19, 1991
- Decision Date
- December 17, 1991
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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Other Clearances by Palco Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942810 | PALCO LABS COLD POUCH | Jun 28, 1995 | Substantially Equivalent |
| K943842 | PULSE OXIMETER MODEL 305 | Mar 24, 1995 | Substantially Equivalent |
| K920066 | PALCO LABS MODEL 340 PULSE OXIMETER | Mar 16, 1993 | Substantially Equivalent |
| K911191 | PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR | Jun 10, 1991 | Substantially Equivalent |
| K904988 | PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR | Mar 18, 1991 | Substantially Equivalent |
| K872233 | INJECT-EASE | Sep 4, 1987 | Substantially Equivalent |
| K842547 | WET-STOP | Oct 19, 1984 | Substantially Equivalent |
| K833344 | AUTO-LANCET | Nov 7, 1983 | Substantially Equivalent |