FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K Number: K900113
·
Decision Mar 28, 1990
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
172
Review Days
78
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Basic Information
- Device Name
- RESPIRONICS' REMSTAR(TM) SLEEPEASY
- K Number
- K900113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Respironics, Inc.
- Date Received
- January 9, 1990
- Decision Date
- March 28, 1990
- Product Code
- BYE
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | FDA class 2 | Anesthesiology |
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