Mdt/Harvey Model 7000 & 8000 Chemiclave
FDA 510(k) K924380 · Mdt Corp., Inc.
510(k) numberK924380
Submission
- Device name
- Mdt/Harvey Model 7000 & 8000 Chemiclave
- Applicant
- Mdt Corp., Inc.
Rochester, NY, US - Received
- August 31, 1992
- Decision date
- February 16, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLR – Sterilizer, Chemical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6860
- Specialty
- General Hospital
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| K233762 | SteroScope® Sterilization Technology SystemMLR · Traditional | Ideate Medical, Inc. | 06/27/2024SE |
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| K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassetteMLR · Traditional | Plasmapp Co,., Ltd. | 05/09/2023SE |
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| K942486 | Image Full Power Examination/Minor Surgery TableFQO · Traditional | 08/10/1994SE |
| K926081 | Dental LightEAZ · Traditional | 01/26/1994SE |
| K924955 | Mdt/Harvey MC-8 and MC-10FLE · Traditional | 10/15/1993SE |
| K932094 | Bovie Ultrasonic Surgical AspiratorLFL · Traditional | 07/21/1993SE |
| K931169 | MDT Dental ChairKLC · Traditional | 05/20/1993SE |
| K920930 | Mdt/Castle 10/90 Dual Load StationFLF · Traditional | 03/31/1993SE |
| K922212 | MDT Castle Biosign Test PackFRC · Traditional | 08/10/1992SE |
| K914758 | Mdt/Shampaine Model 4900B Surgical TableGDC · Traditional | 12/19/1991SE |
Questions and answers
When was Mdt/Harvey Model 7000 & 8000 Chemiclave cleared by the FDA?
Mdt/Harvey Model 7000 & 8000 Chemiclave (K924380) received a 510(k) decision of Substantially Equivalent on February 16, 1994, 534 days after the submission was received.
What is the product code of K924380?
The FDA product code is MLR – Sterilizer, Chemical, a Class II (moderate risk) device regulated under 21 CFR 880.6860.