FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AEQUITRON MED-7100 PHOTOTHERAPY LIGHT
K Number: K850181
·
Decision Apr 5, 1985
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
24
Review Days
77
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Basic Information
- Device Name
- AEQUITRON MED-7100 PHOTOTHERAPY LIGHT
- K Number
- K850181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Aequitron Medical, Inc.
- Date Received
- January 18, 1985
- Decision Date
- April 5, 1985
- Product Code
- LBI
- 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 |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K944654 | OXYGEN CONCENTRATION INDICATOR | Nov 8, 1994 | Substantially Equivalent |
| K914424 | MODEL 6213 REMOTE ALARM | Sep 10, 1992 | Substantially Equivalent |
| K915381 | PORTABLE OXYGEN GENERATOR | Mar 11, 1992 | Substantially Equivalent |
| K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | Sep 19, 1991 | Substantially Equivalent |
| K903020 | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 | Apr 10, 1991 | Substantially Equivalent |
| K905244 | MODEL LP6 VENTILATOR, MODIFICATION | Nov 30, 1990 | Substantially Equivalent |
| K903010 | CONTINUOUS VOLUME VENTILATOR MODEL LP10 | Nov 30, 1990 | Substantially Equivalent |
| K902785 | MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON | Jul 13, 1990 | Substantially Equivalent |