ENGSTROM METABOLIC COMPUTER
FDA 510(k) clearance K821344 · decided 1982-05-28
Clearance details
- K-number
- K821344
- Device name
- ENGSTROM METABOLIC COMPUTER
- Applicant
- Lkb Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-05
- Decision date
- 1982-05-28
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- BZL
- Device class
- 2
- Regulation number
- 868.1730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Lkb Instruments
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 |
|---|---|---|
| Breezing Med (K200076) | Tf Health Co. | 2020-09-25 |
| NICU V'02 (K190561) | Cosmed Nordic Aps | 2020-09-04 |
| ANASCIENT BREATH MONITOR (K110810) | Invoy Technologies, LLC | 2011-06-21 |
| METAPHOR METABOLIC MONITOR (K093080) | Treymed, Inc. | 2010-01-22 |
| FITMATE SERIES (K071533) | Cosmed Srl | 2007-09-28 |
| EXPRESS SERIES (K070858) | Medical Graphics Corp. | 2007-04-16 |
| MEDGRAPHICS ULTIMA SYSTEM (K061731) | Medical Graphics Corp. | 2006-09-06 |
| REEVUE INDIRECT CALORIMETER, MODEL#8100 (K021490) | Korr Medical Technologies, Inc. | 2003-01-02 |
| MEDGEM (K021605) | Healthetech, Inc. | 2002-06-14 |
| BODYGEM, MODEL HB211 (K010577) | Healthetech, Inc. | 2002-01-10 |
| OXYLOG 2 (K954731) | P.K. Morgan , Ltd. | 1997-01-06 |
| 7250 METABOLIC MONITOR (K924978) | Puritan Bennett Corp. | 1994-09-22 |
Recalls involving this device
No recalls on record reference this clearance.