Sapcrill Thermodetect Breast Scanner Dev
FDA 510(k) K801573 · California Cardiac Systems, Inc.
510(k) numberK801573
Submission
- Device name
- Sapcrill Thermodetect Breast Scanner Dev
- Applicant
- California Cardiac Systems, Inc.
Walker, MI, US - Received
- July 9, 1980
- Decision date
- September 9, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYZ – Syringe, Irrigating (Non Dental)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6960
- Specialty
- General Hospital
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| K050797 | Tissu-TransKYZ · Traditional | Shippert Medical Technologies Corp. | 07/13/2005SE |
| K991254 | QS Delivery SystemKYZ · Traditional | Sub-Q, Inc. | 08/23/1999SE |
| K982435 | Irrigation Syringe KitKYZ · Traditional | Sub-Q, Inc. | 11/06/1998SE |
| K974288 | Zerowet SplashieldKYZ · Traditional | Zerowet, Inc. | 01/29/1998SE |
| K964833 | Rmi Dual Fluid Irrigating SyringeKYZ · Traditional | Research Medical, Inc. | 02/19/1997SE |
| K960725 | Marpp Pressure Monitoring SystemKYZ · Traditional | Paradigm Medical, Inc. | 07/15/1996SE |
| K960212 | CPR Irrigation TrayKYZ · Traditional | Custom Pack Reliability | 04/01/1996SE |
Questions and answers
When was Sapcrill Thermodetect Breast Scanner Dev cleared by the FDA?
Sapcrill Thermodetect Breast Scanner Dev (K801573) received a 510(k) decision of Substantially Equivalent on September 9, 1980, 62 days after the submission was received.
What is the product code of K801573?
The FDA product code is KYZ – Syringe, Irrigating (Non Dental), a Class I (low risk) device regulated under 21 CFR 880.6960.