FDA 510(k)
Substantially Equivalent
🇺🇸 United States
PALCO LABS COLD POUCH
K Number: K942810
·
Decision Jun 28, 1995
Classifications
0
FEI Numbers
10
Registration Numbers
10
Same Product Code
80
Applicant Total
9
Review Days
378
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Basic Information
- Device Name
- PALCO LABS COLD POUCH
- K Number
- K942810
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Palco Laboratories, Inc.
- Date Received
- June 15, 1994
- Decision Date
- June 28, 1995
- Product Code
- LDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDQ), ordered by most recent decision date.
Other Clearances by Palco Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943842 | PULSE OXIMETER MODEL 305 | Mar 24, 1995 | Substantially Equivalent |
| K920066 | PALCO LABS MODEL 340 PULSE OXIMETER | Mar 16, 1993 | Substantially Equivalent |
| K913694 | PALCO LABS LOADMATIC | Dec 17, 1991 | 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 |