FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUNG VOLUME & PRESSURE MONITOR
K Number: K771407
·
Decision Aug 4, 1977
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
6
Review Days
6
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Basic Information
- Device Name
- LUNG VOLUME & PRESSURE MONITOR
- K Number
- K771407
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Research Development Corp.
- Date Received
- July 29, 1977
- Decision Date
- August 4, 1977
- 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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Other Clearances by Research Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871870 | HSC UNIT ROD | Jul 21, 1987 | Substantially Equivalent |
| K791730 | RING-ORIFICE, TURBULENT FLOW PNEUMOT | Nov 16, 1979 | Substantially Equivalent |
| K771019 | LUNG-MECHANICS MONITOR | Jun 14, 1977 | Substantially Equivalent |
| K770785 | MONITOR, RESPIRATORY, TWO-GAS, RDC | May 20, 1977 | Substantially Equivalent |
| K770061 | VO RESPIRATORY PNEUMOTACHOGRAPH | Jan 14, 1977 | Substantially Equivalent |