PACER MODEL 100 INFUSION CONTROLLER
FDA 510(k) clearance K963136 · decided 1997-10-10
Clearance details
- K-number
- K963136
- Device name
- PACER MODEL 100 INFUSION CONTROLLER
- Applicant
- Health Watch, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-13
- Decision date
- 1997-10-10
- Days to decision
- 423 days
- Clearance type
- Traditional
- Product code
- LDR
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- South West Ranches, 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 |
|---|---|---|
| DEKA Infusion System, DEKA Administration Set (K242693) | Deka Research and Development Corporation | 2024-10-07 |
| DEKA Infusion System, DEKA Administration Set (K232316) | Deka Research and Development | 2024-03-01 |
| Volumetric Infusion Controller (K153760) | DEKA Research & Development | 2016-10-03 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (K971865) | Alexander Mfg. Co. | 1997-07-03 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 (K971826) | Alexander Mfg. Co. | 1997-07-03 |
| UNIVERSAL CONTROLLER, MODEL 100 (K934543) | Metamed, Inc. | 1994-03-29 |
| FLOW CONTROLLING EXTENSION SET (K935236) | Block Medical, Inc. | 1994-02-24 |
| MASTER FLOW I.V. PUMPETTE (K905497) | The Master Medical Corp. | 1991-04-16 |
| STAT 2 IV PUMPETTE (K905498) | The Master Medical Corp. | 1991-04-16 |
| 3M IV FLOW REGULATOR (K896907) | 3M Company | 1990-02-26 |
| VARI-SET (K894111) | Sonex Medical | 1989-09-28 |
| IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ (K894487) | Y | 1989-09-27 |
Recalls involving this device
No recalls on record reference this clearance.