FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS
K Number: K882229
·
Decision Aug 16, 1988
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
9
Review Days
88
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Basic Information
- Device Name
- AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS
- K Number
- K882229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Biologics Intl., Inc.
- Date Received
- May 20, 1988
- Decision Date
- August 16, 1988
- Product Code
- IOQ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Biologics Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823353 | CARCINO-CEK | Dec 14, 1982 | Substantially Equivalent |
| K812060 | BI-ASO SLIDE TEST | Aug 13, 1981 | Substantially Equivalent |
| K811374 | BI-CRP LATEX TEST | Jun 12, 1981 | Substantially Equivalent |
| K811375 | BI-RA SLIDE TEST | Jun 12, 1981 | Substantially Equivalent |
| K800605 | ANA LATEX SLIDE TEST | Apr 2, 1980 | Substantially Equivalent |
| K791609 | BE-SURE | Oct 2, 1979 | Substantially Equivalent |
| K791607 | BETA-CELL | Sep 24, 1979 | Substantially Equivalent |
| K790898 | PREG-TEX | Jul 30, 1979 | Substantially Equivalent |