COLD CD ASP MODULE, ITE
FDA 510(k) clearance K933041 · decided 1993-08-02
Clearance details
- K-number
- K933041
- Device name
- COLD CD ASP MODULE, ITE
- Applicant
- Electone, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-28
- Decision date
- 1993-08-02
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- LRS
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Longwood, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMSINO I.V. START KIT (K050654) | Amsino International, Inc. | 2005-05-02 |
| INFUSION IV SET (K001879) | Nirvi Intl. USA | 2001-11-20 |
| IV START KIT (K963722) | Grand Medical Products | 1996-11-27 |
| EMS I.V. START KIT (K951167) | Emergency Medical Supply, Inc. | 1995-05-16 |
| B. BRAUN IV START KITS (K950184) | B. Braun of America, Inc. | 1995-03-15 |
| PERSONAL HEARING SYSTEM (K944041) | Resound Corp. | 1994-12-27 |
| SAFESTART VASCULAR ACCESS START KIT (K943941) | Becton Dickinson Vascular Access, Inc. | 1994-10-20 |
| IV START KIT (K935684) | Cush Medical Products | 1994-06-10 |
| I.V. STARTPAK VASCULAR ACCESS START KIT (K942238) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-06-03 |
| IV START KIT (K941469) | Clinical Resources, Inc. | 1994-05-12 |
| IV PREP KIT (NON-STERILE) (K925017) | Customed, Inc. | 1993-08-27 |
| IV PREP KIT W/O DRESSING (NON-STERILE) (K925018) | Customed, Inc. | 1993-08-27 |
Recalls involving this device
No recalls on record reference this clearance.