FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CORD-ASSURE UMBILICAL BLOOD GAS KIT
K Number: K872244
·
Decision Jul 21, 1987
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
15
Review Days
40
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Basic Information
- Device Name
- CORD-ASSURE UMBILICAL BLOOD GAS KIT
- K Number
- K872244
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Lake Medical Products, Inc.
- Date Received
- June 11, 1987
- Decision Date
- July 21, 1987
- Product Code
- CBT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CBT | Arterial Blood Sampling Kit | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBT), ordered by most recent decision date.
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NEEDLE SAFETY COVER
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Other Clearances by Lake Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943162 | LAKE STAGEZERO(TM) AIR FLOTATION BED | Feb 27, 1995 | Substantially Equivalent |
| K922730 | LAKE OSTOMY CARE SET | Dec 30, 1993 | Unknown |
| K905053 | STAGE ZERO AIR FLOTATION BED | Nov 26, 1990 | Substantially Equivalent |
| K901835 | LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR) | Sep 5, 1990 | Substantially Equivalent |
| K902508 | LAKE MALE EXTERNAL CATHETERIZATION KIT | Aug 23, 1990 | Unknown |
| K902121 | LAKE GASTROSTOMY TUBE | Jul 27, 1990 | Substantially Equivalent |
| K884127 | LAKE N/G FEEDING TUBE | Feb 8, 1989 | Substantially Equivalent |
| K884128 | LAKE N/G EXTENSION SET | Dec 8, 1988 | Substantially Equivalent |
| K883610 | LAKE FOLEY CATHETERIZATION TRAY | Oct 12, 1988 | Substantially Equivalent |
| K880578 | LAKE DISPOSABLE PROBE COVER | Mar 31, 1988 | Substantially Equivalent |