Saniserv Surgical Slush System
FDA 510(k) K894006 · Saniserv, Inc.
510(k) numberK894006
Submission
- Device name
- Saniserv Surgical Slush System
- Applicant
- Saniserv, Inc.
Indianapolis, IN, US - Received
- June 5, 1989
- Decision date
- November 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JRM – Freezer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921570 | ORS-300JRM · Traditional | Mnlase, Inc. | 06/09/1992SE |
| K921569 | ORS-200JRM · Traditional | Mnlase, Inc. | 06/09/1992SE |
| K921568 | ORS-100JRM · Traditional | Mnlase, Inc. | 06/09/1992SE |
| K915427 | ORS-1000JRM · Traditional | Mnlase, Inc. | 01/07/1992SE |
| K913777 | Self-Contained Surgical Slush FreezerJRM · Traditional | Taylor Corp. | 09/25/1991SE |
| K782077 | Lancer Ice CubeJRM · Traditional | Sherwood Medical Industries | 04/03/1979SE |
Questions and answers
When was Saniserv Surgical Slush System cleared by the FDA?
Saniserv Surgical Slush System (K894006) received a 510(k) decision of Substantially Equivalent on November 3, 1989, 151 days after the submission was received.
What is the product code of K894006?
The FDA product code is JRM – Freezer, a Class I (low risk) device regulated under 21 CFR 862.2050.