FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PDS MODEL 3000 ADULT RESPIRATION MODULE
K Number: K802046
·
Decision Sep 16, 1980
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
254
Review Days
22
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Basic Information
- Device Name
- PDS MODEL 3000 ADULT RESPIRATION MODULE
- K Number
- K802046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- General Electric Co.
- Date Received
- August 25, 1980
- Decision Date
- September 16, 1980
- Product Code
- BZQ
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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