FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAKE STAGEZERO(TM) AIR FLOTATION BED
K Number: K943162
·
Decision Feb 27, 1995
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
15
Review Days
241
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Basic Information
- Device Name
- LAKE STAGEZERO(TM) AIR FLOTATION BED
- K Number
- K943162
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lake Medical Products, Inc.
- Date Received
- July 1, 1994
- Decision Date
- February 27, 1995
- Product Code
- FNM
- 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 |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FNM), ordered by most recent decision date.
PRESSURE GUARD SITE SELECT (A)
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FDA Class 2
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MIGHTY AIR
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FDA Class 2
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ZAK-2000
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FDA Class 2
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PHYSIO/1000
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SIMPULSE
FDA 510(k)
FDA Class 2
·General Hospital
SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Lake Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K875383 | LAKE CATHETER CARE KITS (MODIFICATION) | Mar 9, 1988 | Unknown |