FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMEDA NEONATAL RESUSCITATION UNIT-
K Number: K832637
·
Decision Dec 22, 1983
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
10
Review Days
140
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Basic Information
- Device Name
- AMEDA NEONATAL RESUSCITATION UNIT-
- K Number
- K832637
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Egnell, Inc.
- Date Received
- August 4, 1983
- Decision Date
- December 22, 1983
- Product Code
- FMT
- 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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Other Clearances by Egnell, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853909 | EGNELL UNIVERSAL SUCTION PUMP | Nov 25, 1985 | Substantially Equivalent for Some Indications |
| K853917 | EGNELL COMPACT SUCTION PUMP | Nov 25, 1985 | Substantially Equivalent for Some Indications |
| K844307 | EGNELL-LACT B BATTERY-OPERATED BREAST PUMP | Feb 4, 1985 | Substantially Equivalent |
| K840526 | AMETHERM | Apr 30, 1984 | Substantially Equivalent |
| K834335 | AMEDA PHOTOTHERAPY LAMP FOR NEWBORN | Apr 20, 1984 | Substantially Equivalent |
| K813312 | UNIVERSAL SUCTION PUMP TYPE EUS | Dec 31, 1981 | Substantially Equivalent |
| K813095 | GASTRIC JUICES SUCTION PUMP | Dec 9, 1981 | Substantially Equivalent |
| K812898 | PE-01 ELECTRONIC INFUSION PUMP | Dec 2, 1981 | Substantially Equivalent |
| K812020 | EGNELL COMPACT, TYPE EHV | Oct 20, 1981 | Substantially Equivalent |