AMB-ALERT
FDA 510(k) clearance K911079 · decided 1991-09-13
Clearance details
- K-number
- K911079
- Device name
- AMB-ALERT
- Applicant
- Medway
- Decision
- Substantially Equivalent
- Date received
- 1991-03-11
- Decision date
- 1991-09-13
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- KMI
- Device class
- 1
- Regulation number
- 880.2400
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Franklin, TN, 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 |
|---|---|---|
| LEAF PATIENT MONITORING SYSTEM (K141877) | Leaf Healthcare, Inc. | 2014-11-10 |
| INTEL-GE CARE INNOVATIONS QUIETCARE (K131585) | Intel-Ge Care Innovations, LLC | 2013-10-08 |
| DYNASENSE SYSTEM (K130752) | Centauri Medical, Inc. | 2013-08-15 |
| VIVATRAK (K101109) | Wireless Medcare, LLC | 2010-07-15 |
| MOBILECARE MONITOR, MODEL 2100 (K090138) | Aframe Digital, Inc. | 2009-04-24 |
| ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR (K942770) | Ultimate Development Corp. | 1994-12-23 |
| INFORMER PLUS (K943481) | Micro-Tech Medical, Inc. | 1994-11-02 |
| PM-PAGER (K933552) | Hill Engineering | 1994-09-22 |
| HOME AMB-ALERT (K934344) | Medway | 1994-04-29 |
| TELETOM (K940405) | Berchtold Holding GmbH | 1994-04-14 |
| SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 (K924433) | Senior Technologies, Inc. | 1993-06-24 |
| WANDER CARE (K925529) | Care Electronics, Inc. | 1993-06-16 |
Recalls involving this device
No recalls on record reference this clearance.