Mon-A-Therm, Inc.
Mchenry, IL, US
Mon-A-Therm, Inc. appears in FDA device records in Mchenry, IL. FDA records list 17 510(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
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Mon-A-Therm, Inc. between 1982 and 1989. The busiest year on record is 1988, with 8. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 3 |
| 1983 | 4 |
| 1985 | 1 |
| 1988 | 8 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K885187 | MODEL 1000 ELECTRONIC CLINICAL THERMOMETER | FLL | Substantially Equivalent | |
| K874522 | MODIFIED MYOCARDIAL TEMPERATURE SENSOR | KRB | Substantially Equivalent | |
| K874519 | MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR | BZW | Substantially Equivalent | |
| K875234 | MON-A-THERM'S SKIN TEMPERATURE SENSOR | FLL | Substantially Equivalent | |
| K874525 | MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR | KOD | Substantially Equivalent | |
| K874524 | MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR | FLL | Substantially Equivalent | |
| K874523 | MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR | FLL | Substantially Equivalent | |
| K874521 | MODIFIED THERMAL WELL TEMPERATURE SENSOR | FLL | Substantially Equivalent | |
| K874520 | MODIFIED AIRWAY TEMPERATURE SENSOR | FLL | Substantially Equivalent | |
| K853392 | MON-A-THERM SUBCUTANEOUS TEMP. SENSOR | FLL | Substantially Equivalent | |
| K830819 | MODIFICATION ELECTRONIC CLINICAL THERMO- | FLL | Substantially Equivalent | |
| K830470 | ANESTHESIA BREATHING CIRCUITS | CAI | Substantially Equivalent | |
| K830552 | LUER LOCK TEMPERATURE SENSOR | FLL | Substantially Equivalent | |
| K823333 | MODEL 400 & 700 TEMP. SENSOR ADAPTERS | FLL | Substantially Equivalent | |
| K821505 | AIRWAY TEMPERATURE SENSOR | GEI | Substantially Equivalent | |
| K821504 | THERMAL WELL TEMPERATURE SENSOR | FLL | Substantially Equivalent | |
| K820426 | TEMPERATURE TREND INDICATOR (TTI) | KPD | 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
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain