JRM — Freezer Class I
FDA product code JRM covers "Freezer", a Class I medical device regulated under 21 CFR 862.2050. Submissions are reviewed by the Clinical Chemistry panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JRM
- Device Class
- Class I
- Regulation Number
- 862.2050
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K921570 | mnlase | ORS-300 | June 9, 1992 |
| K921568 | mnlase | ORS-100 | June 9, 1992 |
| K921569 | mnlase | ORS-200 | June 9, 1992 |
| K915427 | mnlase | ORS-1000 | January 7, 1992 |
| K913777 | taylor | SELF-CONTAINED SURGICAL SLUSH FREEZER | September 25, 1991 |
| K894006 | saniserv | SANISERV SURGICAL SLUSH SYSTEM | November 3, 1989 |
| K782077 | sherwood medical industries | LANCER ICE CUBE | April 3, 1979 |