STRYKER 988 ICU BED
FDA 510(k) clearance K852674 · decided 1985-07-16
Clearance details
- K-number
- K852674
- Device name
- STRYKER 988 ICU BED
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-24
- Decision date
- 1985-07-16
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- FNL
- Device class
- 2
- Regulation number
- 880.5100
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Kalamazoo, MI, 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 |
|---|---|---|
| iBed Wireless with iBed Mobile (K202964) | Stryker Corporation | 2021-06-18 |
| IBED WIRELESS WITH IBED AWARENESS (K103536) | Stryker Corporation | 2010-12-16 |
| VAIL 1000 ENCLOSED BED (K982783) | Vail Products, Inc. | 1998-10-05 |
| MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED (K974296) | Invacare Corp. | 1998-01-06 |
| BENEFIT B3--- SERIES (K974254) | M.C. Healthcare Products, Inc. | 1997-12-16 |
| VOLKER HOSPITAL BED, MODEL K960 (K972115) | Volker Healthcare, Inc. | 1997-08-29 |
| SOMA 900 TRANSPORT BED (K971546) | Nova Technologies, Inc. | 1997-07-10 |
| VAIL 2000 ENCLOSED BED (K963622) | Vail Products, Inc. | 1997-05-07 |
| VAIL 3000 BED ENCLOSURE (K963589) | Vail Products, Inc. | 1997-04-21 |
| TOTALCARE (K962942) | Hill-Rom, Inc. | 1997-02-03 |
| SOMA SAFE ENCLOSURE (K963701) | Nova Technology Corp. | 1997-01-24 |
| NOVABED PATIENT TRANSFER SYSTEM (K964246) | Nova Technology Corp. | 1997-01-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |