INTERCEPT
FDA 510(k) clearance K843591 · decided 1984-10-19
Clearance details
- K-number
- K843591
- Device name
- INTERCEPT
- Applicant
- Vital Signs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-12
- Decision date
- 1984-10-19
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- KDP
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- East Rutherford, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Vital Signs
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 |
|---|---|---|
| BOEHRINGER MRI SUCTION REGULATORY (K013976) | Boehringer Laboratories | 2002-01-08 |
| PM3300 INTERMITTENT VACUUM (K944479) | Precision Medical, Inc. | 1994-12-22 |
| MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) (K942747) | Engineered Orthopedic Technologies, Inc. | 1994-07-21 |
| BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED (K933232) | Boehringer Laboratories | 1994-03-28 |
| VACUUM POWER BODY FLUID SUCTION APPARATUS (K926140) | Hill-Rom, Inc. | 1993-07-27 |
| PM3000 & PM3100 VACUUM REGULATOR (K922817) | Precision Medical, Inc. | 1993-03-04 |
| OHMEDA CONTINUOUS SUCTION REGULATOR (K883229) | Ohmeda Medical | 1988-10-19 |
| VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (K875074) | Timeter Instrument Corp. | 1988-02-22 |
| BOEHRINGER LAB SUCTION INTERRUPTER (K853155) | Boehringer Laboratories | 1985-10-16 |
| SUCTION REGULATOR 7700 SERIES (K850200) | Boehringer Laboratories | 1985-03-04 |
| VACUUM REGULATOR 0-2000 MMHG VR-1000 (K834224) | Trimeter Instrument Corp. | 1984-02-27 |
| THORACIC GAUGE #TG-60 -VACUUM REGULATOR (K831505) | Sorensen Research | 1983-07-12 |
Recalls involving this device
No recalls on record reference this clearance.