FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO FLOTE(R)
K Number: K900131
·
Decision Feb 16, 1990
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
14
Review Days
37
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Basic Information
- Device Name
- BIO FLOTE(R)
- K Number
- K900131
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Bio Clinic Co.
- Date Received
- January 10, 1990
- Decision Date
- February 16, 1990
- 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
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SIMPULSE
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SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
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|---|---|---|---|
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| K922140 | ORTHODERM CONVERTIBLE II | May 27, 1992 | Substantially Equivalent |
| K921212 | MIRCO ELISA HPL TEST KIT | May 7, 1992 | Substantially Equivalent |
| K921211 | NOW PREGNANCY TEST KIT | May 7, 1992 | Substantially Equivalent |
| K920920 | ELISA TUBE LH TEST KIT | Apr 8, 1992 | Substantially Equivalent |
| K920921 | ELISA TUBE PROLACTIN TEST KIT | Apr 8, 1992 | Substantially Equivalent |
| K920918 | TMB CHROMOGEN/SUBSTRATE REAGENT SET | Apr 7, 1992 | Substantially Equivalent |