FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRICKET 2000 RECORDING PULSE OXIMETER
K Number: K972829
·
Decision Oct 28, 1997
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
172
Review Days
90
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Basic Information
- Device Name
- CRICKET 2000 RECORDING PULSE OXIMETER
- K Number
- K972829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics, Inc.
- Date Received
- July 30, 1997
- Decision Date
- October 28, 1997
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQA), ordered by most recent decision date.
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Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
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