LABMASTER & CRSI 600
FDA 510(k) clearance K843435 · decided 1985-05-15
Clearance details
- K-number
- K843435
- Device name
- LABMASTER & CRSI 600
- Applicant
- Control Resource Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-04
- Decision date
- 1985-05-15
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- FRF
- Device class
- 2
- Regulation number
- 880.5045
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Control Resource Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Biomoneta Avata Rx (K251872) | Biomoneta Research Private Limited | 2025-11-14 |
| CerroZone Mini (K242102) | Cerrozone, LLC | 2024-11-19 |
| Airdog X8 Air Purifier (KJ800F-X8) (K240696) | Suzhou Beiang Smart Technology Co., Ltd. | 2024-06-14 |
| MA-40, MA-112 (K223835) | Medify Air, LLC | 2023-09-18 |
| RIA Safeguard (K222416) | Ria Tech Co., Ltd. | 2023-05-01 |
| Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) (K211507) | Beiang Air Tech , Ltd. | 2022-11-22 |
| Qorda QD1 (K220990) | Winix, Inc. | 2022-09-14 |
| CerroZone Mobile (K220298) | Cerrozone | 2022-07-01 |
| Novaerus NV1050 (K200321) | Novaerus Us, Inc. | 2020-12-28 |
| AIRSONETT AIR-4 (K130702) | Airsonett AB | 2013-07-23 |
| HEPAIRX VENTILATING AIR PURIFIER (K112728) | Air Innovations, Inc. | 2013-01-23 |
| AIRSONNETT AIRSHOWER AIR 3 (K081062) | Airsonett, Inc. | 2008-11-07 |
Recalls involving this device
No recalls on record reference this clearance.