FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEVILBISS SLEEP RECORDER MODEL # RM60
K Number: K012437
·
Decision Jul 16, 2002
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
10
Review Days
350
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Basic Information
- Device Name
- DEVILBISS SLEEP RECORDER MODEL # RM60
- K Number
- K012437
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sunrise Medical Hhg, Inc.
- Date Received
- July 31, 2001
- Decision Date
- July 16, 2002
- Product Code
- MNR
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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