MULTIPLE, ENT CABINET #448
FDA 510(k) clearance K822531 · decided 1982-09-28
Clearance details
- K-number
- K822531
- Device name
- MULTIPLE, ENT CABINET #448
- Applicant
- Midmark Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-23
- Decision date
- 1982-09-28
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- ETF
- Device class
- 1
- Regulation number
- 874.5300
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, 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 |
|---|---|---|
| JEDMED SPECTRUM ENT CABINET (K953457) | Jedmed Instrument Co. | 1995-08-11 |
| PREMIER MIRROR WARMER (K945395) | Premier Dental Products Co. | 1995-01-18 |
| LANGGASSE 90 (K932470) | Happersberger Otopront GmbH | 1993-08-25 |
| MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE (K911901) | Stortz | 1991-07-26 |
| #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES (K910781) | Midmark Corp. | 1991-05-15 |
| MOBILE TREATMENT CART (K910243) | Jedmed Instrument Co. | 1991-04-17 |
| SYSTEMA ENT CABINET (K896273) | Jedmed Instrument Co. | 1990-01-26 |
| JEDMED S CHAIR (K896298) | Jedmed Instrument Co. | 1990-01-26 |
| JEDMED MAXIM ENT CABINET (K881958) | Jedmed Instrument Co. | 1988-07-15 |
| MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT (K860940) | Micromedics, Inc. | 1986-05-02 |
| LARYNGEAL MIRROR PRE-WARMER (K855021) | Jedmed Instrument Co. | 1986-03-20 |
| RELIANCE TREATMENT CABINET (K843046) | F. & F. Koenigkramer | 1984-09-27 |
Recalls involving this device
No recalls on record reference this clearance.