Product code JRM
- Device name
- Freezer
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2050
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921568 | ORS-100 | Mnlase, Inc. | 1992-06-09 |
| K921569 | ORS-200 | Mnlase, Inc. | 1992-06-09 |
| K921570 | ORS-300 | Mnlase, Inc. | 1992-06-09 |
| K915427 | ORS-1000 | Mnlase, Inc. | 1992-01-07 |
| K913777 | SELF-CONTAINED SURGICAL SLUSH FREEZER | Taylor Corp. | 1991-09-25 |
| K894006 | SANISERV SURGICAL SLUSH SYSTEM | Saniserv, Inc. | 1989-11-03 |
| K782077 | LANCER ICE CUBE | Sherwood Medical Industries | 1979-04-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06949573502594 | Haier Biomedical | Qingdao Haier Biomedical Co Ltd | 2026-01-05 |
| 06949573501702 | Haier Biomedical | Qingdao Haier Biomedical Co Ltd | 2025-10-09 |
| 06949573500460 | Haier | Qingdao Haier Biomedical Co Ltd | 2025-01-23 |
| 06949573501443 | Haier | Qingdao Haier Biomedical Co Ltd | 2025-01-23 |
| 06949573501450 | Haier | Qingdao Haier Biomedical Co Ltd | 2025-01-23 |
| 00816394021824 | Farrar | HELMER, INC. | 2025-01-10 |
| 06949573525067 | Haier | Qingdao Haier Biomedical Co Ltd | 2023-04-12 |
| 06949573525074 | Haier | Qingdao Haier Biomedical Co Ltd | 2023-04-12 |
| 06949573547717 | Haier | Qingdao Haier Biomedical Co Ltd | 2023-04-12 |
| 06949573548516 | Haier | Qingdao Haier Biomedical Co Ltd | 2023-04-12 |
| 06949573555231 | Haier | Qingdao Haier Biomedical Co Ltd | 2023-04-12 |
| 06949573525623 | Haier | Qingdao Haier Biomedical Co Ltd | 2023-04-07 |
| 03661532003067 | CBS INTEGRAL FREEZER | CRYO BIO SYSTEM | 2020-10-30 |
| 10885380171116 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2020-06-21 |
| 10885380171109 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2020-06-21 |
| 10885380171147 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2020-06-21 |
| 10885380171154 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2020-06-21 |
| 05450104548338 | B Medical Systems | B Medical Systems SARL | 2020-06-17 |
| 05450104548291 | B Medical Systems | B Medical Systems SARL | 2020-05-04 |
| 05450104548369 | B Medical Systems | B Medical Systems SARL | 2020-05-04 |
| 05450104548383 | B Medical Systems | B Medical Systems SARL | 2020-05-04 |
| 05450104548260 | B Medical Systems | B Medical Systems SARL | 2020-04-17 |
| 05450104548277 | B Medical Systems | B Medical Systems SARL | 2020-04-17 |
| 10885380164545 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2020-03-18 |
| 10885380164552 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2020-03-18 |
| 05450104548307 | B Medical Systems | B Medical Systems SARL | 2020-03-04 |
| 05450104548390 | B Medical Systems | B Medical Systems SARL | 2020-03-04 |
| 00816394021640 | Helmer | HELMER, INC. | 2019-01-31 |
| 00816394021626 | Helmer | HELMER, INC. | 2019-01-31 |
| 00816394021619 | FARRAR | HELMER, INC. | 2019-01-31 |