FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 1010, CY-MET
K Number: K884910
·
Decision Jun 12, 1989
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
11
Review Days
199
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Basic Information
- Device Name
- MODEL 1010, CY-MET
- K Number
- K884910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1850
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Cybermedic, Inc.
- Date Received
- November 25, 1988
- Decision Date
- June 12, 1989
- Product Code
- BZK
- 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 |
|---|---|---|---|
| BZK | Spirometer, Monitoring (W/Wo Alarm) | FDA class 2 | Anesthesiology |
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Other Clearances by Cybermedic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941813 | VENSHIELD | May 3, 1994 | Substantially Equivalent |
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| K903959 | NEONATAL METASCOPE | Nov 23, 1990 | Substantially Equivalent |
| K861418 | SPINNAKER | May 9, 1986 | Substantially Equivalent |
| K851197 | CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH | Jul 8, 1985 | Substantially Equivalent |
| K842782 | PHYSIOLOGICAL ANALYZER CM-710 | Aug 17, 1984 | Substantially Equivalent |
| K842760 | LUNG ANALYZER CM-310 | Jul 26, 1984 | Substantially Equivalent |
| K831586 | CM-VII PHYSIOLOGIC ANALYZER | Mar 19, 1984 | Substantially Equivalent |
| K800547 | MEDISTOR III LUNG ANALYZER | Mar 25, 1980 | Substantially Equivalent |
| K790579 | MEDISTOR II | Apr 4, 1979 | Substantially Equivalent |