Egnell, Inc.
Mchenry, IL, US
Egnell, Inc. appears in FDA device records in Mchenry, IL. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Egnell, Inc. between 1981 and 1985. The busiest year on record is 1981, with 4. The most recent is 1985, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 4 |
| 1983 | 1 |
| 1984 | 2 |
| 1985 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K853917 | EGNELL COMPACT SUCTION PUMP | BTA | Substantially Equivalent for Some Indications | |
| K853909 | EGNELL UNIVERSAL SUCTION PUMP | BTA | Substantially Equivalent for Some Indications | |
| K844307 | EGNELL-LACT B BATTERY-OPERATED BREAST PUMP | HGX | Substantially Equivalent | |
| K840526 | AMETHERM | FMZ | Substantially Equivalent | |
| K834335 | AMEDA PHOTOTHERAPY LAMP FOR NEWBORN | LBI | Substantially Equivalent | |
| K832637 | AMEDA NEONATAL RESUSCITATION UNIT- | FMT | Substantially Equivalent | |
| K813312 | UNIVERSAL SUCTION PUMP TYPE EUS | BTA | Substantially Equivalent | |
| K813095 | GASTRIC JUICES SUCTION PUMP | BTA | Substantially Equivalent | |
| K812898 | PE-01 ELECTRONIC INFUSION PUMP | FRN | Substantially Equivalent | |
| K812020 | EGNELL COMPACT, TYPE EHV | BTA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain