Medistor III Lung Analyzer
FDA 510(k) K800547 · Cybermedic, Inc.
510(k) numberK800547
Submission
- Device name
- Medistor III Lung Analyzer
- Applicant
- Cybermedic, Inc.
Mchenry, IL, US - Received
- March 10, 1980
- Decision date
- March 25, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZC – Calculator, Pulmonary Function Data
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1880
- Specialty
- Anesthesiology
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| K941813 | VenshieldBYD · Traditional | 05/03/1994SE |
| K914205 | PFF-1BZG · Traditional | 05/01/1992SE |
| K903959 | Neonatal MetascopeBZK · Traditional | 11/23/1990SE |
| K884910 | Model 1010, Cy-MetBZK · Traditional | 06/12/1989SE |
| K861418 | SpinnakerBZC · Traditional | 05/09/1986SE |
| K851197 | Cybermedic CM-810 Body PlethysmographJEH · Traditional | 07/08/1985SE |
| K842782 | Physiological Analyzer CM-710BZM · Traditional | 08/17/1984SE |
| K842760 | Lung Analyzer CM-310BZC · Traditional | 07/26/1984SE |
| K831586 | Cm-Vii Physiologic AnalyzerBZM · Traditional | 03/19/1984SE |
| K790579 | Medistor IIBTY · Traditional | 04/04/1979SE |
Questions and answers
When was Medistor III Lung Analyzer cleared by the FDA?
Medistor III Lung Analyzer (K800547) received a 510(k) decision of Substantially Equivalent on March 25, 1980, 15 days after the submission was received.
What is the product code of K800547?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.