Star Calc
FDA 510(k) K875027 · Infrasonics Corp.
510(k) numberK875027
Submission
- Device name
- Star Calc
- Applicant
- Infrasonics Corp.
San Diego, CA, US - Received
- December 7, 1987
- Decision date
- August 16, 1988
- 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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| K150810 | Vyntus / SentrySuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/14/2015SE |
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| K102047 | Lci Option for InnocorBZC · Traditional | Innovision A/S | 11/01/2011SE |
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| K934753 | Star Breathing CircuitsBZO · Traditional | 10/27/1993SE |
| K922654 | Ventilator Adult Star ModificationCBK · Traditional | 12/01/1992SE |
| K923704 | Infant Star Series 500CBK · Traditional | 10/22/1992SE |
| K922477 | Model 105 Ventilator, ModificationCBK · Traditional | 08/24/1992SE |
| K920954 | Air StarBTI · Traditional | 08/03/1992SE |
| K911804 | Infrasonics Ventilator Adult Star, ModificationCBK · Traditional | 06/11/1992SE |
| K913972 | Star Sync, ModificationCBK · Traditional | 01/09/1992SE |
| K905272 | Adult Star, ModificationCBK · Traditional | 01/30/1991SE |
Questions and answers
When was Star Calc cleared by the FDA?
Star Calc (K875027) received a 510(k) decision of Substantially Equivalent on August 16, 1988, 253 days after the submission was received.
What is the product code of K875027?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.