FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MATTRESS, AIR FLOATATION, ALTERN. PRESS.
K Number: K803307
·
Decision Jan 13, 1981
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
6
Review Days
14
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Basic Information
- Device Name
- MATTRESS, AIR FLOATATION, ALTERN. PRESS.
- K Number
- K803307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Intl. Medical Equipment Corp.
- Date Received
- December 30, 1980
- Decision Date
- January 13, 1981
- 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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SIMPULSE
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SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
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Other Clearances by Intl. Medical Equipment Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K832745 | OC3 FLYER | Sep 20, 1983 | Substantially Equivalent |
| K832325 | BASE ONLY, POWER WHEELCHAIR | Aug 12, 1983 | Substantially Equivalent |
| K832321 | ACCES. HEAD CONTROL-POWERED CHEELCHAIR | Aug 12, 1983 | Substantially Equivalent |
| K832322 | BASE ONLY, TORONTO CHAIR | Aug 12, 1983 | Substantially Equivalent |
| K813104 | POWER DRIVE WHEELCR | Nov 20, 1981 | Substantially Equivalent |